17
May
2016
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Oregon Defective Medical Device Lawyer Discusses Recall

Oregon Defective Medical Device Lawyer Discusses Recall of Two Million Defective Huber Needles

The U.S. Food and Drug Administration (“FDA”) has 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. The recall affects over two million medical products that may put patients at risk.

The International Sharps Injury Prevention Society describes a Huber needle as one that is used to administer chemotherapy, antibiotics, and total parenteral nutrition through an implanted IV port. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins. They may remain in the port for extended periods, making them difficult to remove. Huber needles are designed with guards that retract or shield the needle upon removal from the implanted port, preventing the potential of recoil resulting in an accidental needlestick.

Needles subject to the recall, however, were found to cut and dislodge silicone cores or slivers from the ports into which they are inserted. Needles penetrating ports could carry this dislodged silicone into patients’ bodies. The recall’s designation as Class I—the most serious—indicates that the defective medical devices may also carry a high risk of death or injury. The FDA notes that if the needle pushes a silicone sliver into a patient, it could lead to decreased effectiveness of the port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia (inadequate blood supply), stroke, and local extravasation (forcing out) of medication such as chemotherapy or other caustic material.

The FDA has not yet received any adverse event reports related to silicone foreign bodies released in patients by Huber needles. It warned, however, that it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, leading to potential under-reporting.