Archive for January, 2010

Huber Needle Recall


January 30th, 2010

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.

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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The Year of Nora!


January 24th, 2010

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. :)

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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.

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Nora snuggeling up to our good ol’ cat Maxwell.

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

0401.JPG Watch out world, here I come!

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