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Original Date Issued: January 26, 2010
Date updated: August 26, 2010
Audience: Healthcare Practitioners and Patients/Caregivers
Medical Specialties: Multiple, including Interventional Radiologists, Oncologists, Infusion Nurses
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.
The core: part of septum
material cut by the sharp
needle heel.
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Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be non-coring), the agency conducted its own laboratory testing of Huber needles from multiple manufacturers. This testing showed that certain Huber needles produced cores when inserted into ports.
UPDATE: August 26, 2010
FDA continues its investigation through the inspection of Huber needle manufacturers. Inspections found increases in incidents of coring with Huber needles. The agency is continuing its investigation and will update the public if there are new developments. FDA is working with manufacturers to implement coring tests to detect and reduce the occurrence of coring in Huber needles. See FDA Activities below for recalls.
FDA has received reports related to silicone foreign bodies released from Huber needles after accessing an implantable port. The agency has also received 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 adverse events.
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While a more thorough investigation of this situation continues, FDA continues to recommend that health care professionals consider taking the following precautions:
Avoid flushing the syringe when initially confirming needle 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.
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On August 26, 2010, the FDA announced a Class I recall of certain models and lot numbers of Multi-Med, Inc. 22 Gauge x 1” straight Huber needles and 22 Gauge Right Angle x 1” Huber needles. These Huber needles were sold exclusively to Navilyst Medical, Inc. Navilyst distributed the needles as a component of Vaxel Implantable Port Systems. Navilyst Medical, Inc. purchased Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxel Implantable Port Systems may have Boston Scientific labeling.
Inspections conducted on samples of needles collected from Navilyst in September and November 2009 found two lots of Multi-Med needles that produced cores. WEAC’s testing results determined 23 to 86 percent of Navilyst’s sample lots collected cored. More than 54,000 units are subject to this recall. These devices were manufactured from May 2, 2007 to May 1, 2010 and were distributed from May 2, 2007 to May 1, 2010.
The affected units include:
Multi-Med, Inc.
22 Gauge x 1” straight Huber needles
Model 10600218, Lot 9B020M22 Gauge Right Angle x 1” Huber needles
Model 10600219, Lot 9B017M
Navilyst Medical, Inc.*
Certain lots of Vaxcel Implantable Vascular Access Systems with PASV Valve TechnologyCertain lots of Vaxcel Implantable Vascular Access Systems
* Navilyst Medical Inc. bought Boston Scientific Oncology Division in 2008; therefore, some recalled Vaxcel Implantable Vascular Access Systems are labeled as Boston Scientific products.
See the recall notice for a complete listing of the affected products.
Facilities that have products affected by the recall should immediately discontinue the use of the needles and return unused product to Navilyst Medical, Inc. Navilyst Medical, Inc. may be contacted at 800-833-9973 between 8:30 AM and 7:00 PM Eastern Standard Time and by fax at 518-742-4450.
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On January 26, 2010, the FDA 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.
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. Exelint does not export the Huber needles after receiving them from their Japanese contract manufacturer. We are not aware of Nipro exporting to other countries from Japan. 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:
26901
26902
26904
26906
26907
26908
26909
26911
26921
26922
26923
26924
26925
With/Injection Site:
27940R
27941R
27944R
27945R
27946R
27948R
27949R
27950R
Without/Injection Site Product Codes/Catalog Numbers:
27954R
27955R
27958R
27959R
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
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In 2009, the FDA issued a letter to manufacturers of other Huber needles to address design and manufacturing concerns. The FDA continues to work closely with all manufacturers of Huber needles to understand the potential causes for coring and identify corrective measures
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Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect coring problems with Huber needles, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device manufacturers must comply with the Medical Device Report (MDR) regulations
To help us learn as much as possible about the adverse events associated with Huber needles, please include the following information in your reports, if available:
Patient information (age, indication for use, existing medical conditions)Details of the adverse eventTherapy being infusedPort information (type, manufacturer, anatomical location)Type of Huber needle used (manufacturer, lot/serial numbers)Unexpected health issues (such as stroke or MI)
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If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.
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Other documents associated with this issue can be found at:
http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm198719.htm
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This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.
For the purpose of these guidelines, in so far as it is not, as a matter of routine, "do not use positive pressure connectors mechanical valves before needleless risks, benefits and proper management of a