Intravenous products: The FDA report “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.”