There has been a recall issued on certain lot numbers of Exel/Exelint Huber needles. Thankfully this is not the kind that Nora uses but I wanted to pass along the information because it is very important that anyone who has a port or who’s child has a port make sure that they are not using any of these needles. The recalled needles can puncture the silicone membrane of the port which can lead to serious health risks and could damage the port to where it would have to be surgically replaced.

Click this link to read the full article on the FDA website:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198676.htm

or you can read the article below:

FDA NEWS RELEASE

For Immediate Release: Jan. 26, 2010
Media Inquiries: Peper Long, 301-796-4671, mailto:mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Announces Class I Recall of Certain Infusion Set Needles
Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.
Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

Inspections conducted in October 2009 of Nipro facilities in Japan found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate.

There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the following product codes or catalog numbers:
Exel/Exelint Huber Needles Product Codes/Catalog Numbers
26901
26902
26904
26906
26907
26908
26909
26911
26921
26922
26923
26924
26925
Exel/Exelint Huber Infusion Sets Product Codes/Catalog Numbers
With/Injection Site:
27940R
27941R
27944R
27945R
27946R
27948R
27949R
27950R

Without/Injection Site Product Codes/Catalog Numbers:
27954R
27955R
27958R
27959R

Exel/Exelint “SecureTouch +” Safety Huber Sets Product Codes/Catalog Numbers:
37854S
37855S
37858S
Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. Direct all questions concerning this recall to:

Attn: Armand Hamid
EXEL International
5408 West Centinela Ave
Los Angeles, Calif. 90045-1504
Tel. 800-940-3935
Fax 800-308-5048
E-mail: info@exelint.com
Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted it own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports. However, at this time only needles manufactured by Nipro have shown a high frequency for coring. The agency is continuing its investigation and will update the public if there are new developments.

At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring.The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.

The agency has issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns.

“The agency’s laboratory work helped determine the coring problem, and we will continue to work with manufacturers to address coring issues as quickly and thoroughly as possible,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The FDA continues to work closely with all 20 manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures. While a more thorough investigation of this situation continues, the FDA recommends that health care professionals consider taking the following precautions, which will be posted on the FDA’s Web site, when accessing implanted ports with Huber needles:

• Avoid flushing the syringe when initially confirming needles patency upon accessing the port. If the needle has cored the port, flushing may introduce the core into the patient’s body, and could lead to serious adverse events.
• When possible, upon accessing the port, consider aspirating a small amount of blood from the port after septum puncture, then discard the syringe with its contents. This step may recapture the silicone sliver. If the needle becomes clogged when attempting to aspirate, remove the needle, discard it and select a new one.
•  Watch for signs and/or symptoms that may indicate damage to the port’s septum, such as medication leakage resulting in inadequate therapy delivery, along with tissue, nerve and/or muscle damage; and redness of the surrounding area.
• Patients should continue to follow their doctor’s recommendations for receiving treatment.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online: http://www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

FDA Information on Nipro Huber Needle Recall:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87821
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87830

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It’s hard to believe that the first month of the new year is already almost gone. Our little family has been busy with typical life stuff and Nora is chugging along and doing great.

We wrapped up 2009 with a trip to the Sopchoppy River to visit my dear friend Ida who was in town for the holidays. Her parents live right on the river so we got a chance to take Nora out in a canoe for the very first time. It was just a short stroll in the water to see what she thought about it all and she did great and loved every minute of it. Before Nora was born canoeing was a regular hobby of ours which we haven’t done since my early pregnancy. You can see by the smiles on my face that this experience made me one happy mamma.

Watch out 2010, this is only the beginning….I see many canoe trips and more fun adventures than ever before in our near future. I am proclaiming 2010 as the Year of Nora! Not to sound braggadocios but I am saying it with pure optimism and hope, although I’m never shy to brag about my girl.

Each year since Nora has been born has come with many challenges and hardships but they have also come with overwhelming happiness and amazement at the many huge successes our Nora girl has made. Medically and socially I just can’t help but believe that this will be Nora’s biggest year yet. We have high hopes of finally getting Nora off of TPN for good this year. She has really beefed up her oral intake and is only on 3 nights of 335ml TPN which is a very low dose. We’ve been talking with her GI doctor and nutritionist and plan to start decreasing her TPN even more soon. The plan will be to take her off Omgaven first to see if she can handle not getting fats intravenously and go from there. But even if this isn’t the year for her to be able to get off TPN completely we know she’ll continue to make leaps and bounds.

Nora snuggeling up to our good ol’ cat Maxwell.

Nora had a nice visit with her Uncle Kia (Montana’s brother) this weekend.

With her fishing hat from Uncle Kia and her boots Nora is all ready for a fishing trip!

On the social front, we are planning to finally get Nora up to visit my family in Kentucky this spring. This is something we’ve been long awaiting and very much looking forward too. Some time on my dad’s farm and visiting with family is just what we need. We will still be cautious with Nora when it comes to germ exposure but we are really planning to open up her social horizon more than ever this summer and hope to have many play dates with friends and family.

Watch out world, here I come!

Oh what a year it’s been……as I sit here on the last morning of the year thinking back on the last 12 months and watching Nora play with all of her Christmas toys it makes my heart smile to just observe the pure miracle of her.

Then she asks me to close her up in her new castle tent, I peek in the window to see what she’s up to and she sweetly says “I want you to go bye-bye now mommy” and then my ushy gushy heartfeltness turns into laughing out loud and amazement in what independence my little Nora already has. That independence became very apparent on Christmas morning when we heard “I want to do it myself” many times every time we would try to show her how to work one of her new toys….oh what a stinker.

Christmas Eve delivered a very special present for all of us, Santa Crooms, I mean Dr. Crooms came by to visit Nora and bring her a present between surgeries…..amazing…. is the only word that comes to mind. We are so very blessed to have him in our lives. Who would have ever thought 32 months ago on the day that Nora was born such a special bond would have been formed between Dr. Crooms and our family.

To say that Nora loved her puppy from Dr. Crooms would be an understatement.

We know that Nora is a very special girl as well as a very special medical case. But we also know that Dr. Crooms has preformed many life saving surgeries and has probably saved the life of a newborn before. But we’ve always wondered why Nora made such a strong impression on Dr. Crooms for him to take such a personal interest but of course not wanting to be too blunt to ask him to explain. Well I think we got our answer when I called to wish him a Merry Christmas on Christmas day and thank him for taking the time to visit Nora. I was telling him how much we appreciated him being in Nora’s life outside of the medical world and he said “I will be a part of Nora’s life as long as I am around. She is such a special miracle and reminds us all of how life should be.”

Thank you Dr. Crooms, thank you with all of our heart and soul for saving Nora’s life and being such a wonderful, caring person.

Christmas morning

So many presents for one little girl, a brunch break was required to keep up the Christmas marathon…..

Sooo happy

An afternoon tea party in her new PJ’s

More Christmas celebrating into the evening and Nora helped with the cooking.

We hope everyone had a very Merry Christmas and wishing you a very happy New Year!

I can’t believe Nora’s third Christmas is the day after tomorrow. We have been having lots of fun getting ready for Santa and Nora is getting quite excited as well as we are. I was looking back at Christmas pictures from last year, it’s so amazing to see how much she has grown and matured. We only thought she was big stuff last year. But this year….look out, Nora is in full effect and knows all about Christmas and the goodies that come along with it. She’s already accidentally found my secret hiding spot for some of her gifts, obviously I need to get better at hiding gifts from such a big curious girl. The other day I hear her screaming from the back of the house “mommy! mommy! come here!” I ran back there thinking she found a spider or something that scared her but no, instead she was screaming in excitement because she got a peek of her new Wubbzy doll. Thankfully she didn’t see Wubbzy’s friend Daisy who she requested from Santa along with more books and puzzles. Although I think she’s too young still to wonder why Santa’s gift was here before Christmas but we’ve learned to never under estimate Nora’s smarts, because she has quite a lot of them.

Picking out the tree

Nora tried on her Christmas dress last week and it made her so excited she put on her boa and got dancing fever. Nora is one dancing, singing little cutie pants. I’ve been counting up all the songs she sings word for word, she’s up to at least 15 songs and the list is still growing with her adding Christmas songs to her repatwar. Yesterday she made up her first original song which I’m sure will fast become a greatest hit. “Turn around and touch your knees, I love singing my ABC’s!”

Click here to see Nora busting wiggly moves in her Christmas dress

Click here to see part 2 of Nora dancing in her “fancy shoes”

Click here to see Nora singing Jingle Bells
(sorry for the darkness of the video, it was taken in at night the car on the way to see Christmas lights)

Nora is doing great…. eating good, overall having good BM’s, gaining good weight and growing tall. I haven’t measured her in a while but I know she’s gaining length by the way a lot of her pants have turned into highwaters all of a sudden. We are very happy with her progress and are looking forward to starting off the new year, I have a feeling it’s going to be the best one yet.

(as you can see, Nora is quite fond of her boa)

MERRY NORA CHRISTMAS!

We have added a new blog category (on the left side menu) to include a Nora photo site for those of you who just can’t get enough of our precious sweetheart! I will continue to post pictures on this blog but we take so many more pictures than I post and we wanted to have a separate site to be able to share more pics with friends and family. Enjoy!

This Thanksgiving was full of all of the things we are so very thankful for…..family, love, sharing, and of course Nora! My parents, grandparents and brother were so sweet and drove down from KY to join us. My sister and her family were also planing to join us but my niece Marin got sick at the last minute. We hope you feel all better soon sweetheart!

We only had a few days with my family so we made sure to make the best of our time together and had an adventure packed visit. Nora took her very first boat ride on the Wakulla River. She had a blast looking over the side of the boat to see alligators, manatees, turtles, fish and lots of different kinds of river birds.

But as impressive as all those animals were, a little brown squirrel gave her the most entertainment. He was burying an acorn for the winter and Nora couldn’t stop laughing at it’s frantic digging and pounding the acorn into the ground. She was laughing so hard my grandparents heard her laughing from all the way across the park.

Thanksgiving dinner was extra special this year, not only for the great company but it was the first year Nora got to eat a real turkey dinner and the same menu as the rest of us. Turkey, mashed potatoes, cranberry sauce, green beans (hulled) and pumpkin pie made with goat milk just for Nora by her sweet Mammie, yum! And it was even better that her tummy handled all of it great.

After we stuffed ourselves we took Nora to walk around and see the Christmas lights at Dorothy B. Oven park. Nora is definitely going to enjoy Christmas this year more than ever and is already getting very excited about it.

It was so great for my family to be able to join in the Nora fun. She is such a special little girl who we will forever be so very thankful for.

Nora’s port definitely has some issues but they are manageable for now and we’ll just keep using it as it is until it stops working which hopefully wont be anytime soon. The first issue is that her port is not flat against her chest but is in at an angle, so now we know to put the needle in at that same angle instead of straight on and that explains why getting it in has been an issue. After the initial x-ray was taken showing how the port was laying, we put a needle in and injected some dye to see what the catheter was doing. The catheter had recoiled back up the artery a good bit so instead of being at a gradual arch from her port over to her heart it’s at a sharp turn. So just like with a water hose things don’t flow as smoothly as they would if it were at a straighter angle. Anther thing going on with the catheter is since it’s recoiled and not hanging down in the big artery right above her heart, it’s now in a smaller artery and the end of it is up against the artery wall, so that explains why we can’t get blood return sometimes because it’s making a vacuum against the wall. But it does move around in the vein a bit so moving Nora’s position should move it off the wall enough to be able to pull blood. Thankfully Nora only gets labs drawn monthly so drawing blood wont be a weekly issue. Lastly, it looked like there was a bit of fibrous clot forming at the end of the catheter causing even more blockage issues. But the clot is still small and if it gets bigger it can be easily be broken up by injecting a certain solution.

So it’s far from perfect but it still works and no surgery was needed and that makes us all sigh a big sigh of relief. Dr. Crooms was with us every step of the way this morning and left it up to us whether to go in and straighten out the catheter now but we don’t want to put Nora through even a minor surgery unless absolutely necessary. He agreed with our decision and as long as Nora’s TPN can infuse with out occluding than that’s the most important thing. And now that we have a clear picture of what’s going on inside working her port should be much easier from now on, and less stressful. Even though there are multiple issues going on none of them are putting Nora in any danger, especially since we’ll continue to go by the golden port rule of not forcing anything in or out. If it doesn’t come with gentle pressure then we’ll know to give it a rest and try again later.

Since I know I’ll get fussed at if I make two posts in a row with no pics I’ll wrap this up with some funny pictures of our silly girl that have been taken over the past few weeks.