Development of a Coring Test for Non-Coring Huber Needles

Huber needles were designed to penetrate an implantable port septum without producing cores, or shaving off slivers of material from the septum which can cause the port to leak or fail. Needles with manufacturing flaws resulting in sharp rear bevel edges [1] have been undetected in some products. That sharp rear bevel edge (sharp anti-coring heel) is the major factor in producing cores (i.e. plugs of septum material) during the septum perforation. When a core is produced the small piece of silicone (a core) can be flushed from the needle into the port, possibly entering the blood vessel. This can lead to adverse health events. In recent years about two million Huber needles were voluntarily recalled from the market due to the possibility of coring. There is no standardized coring test for Huber needles. Some manufacturers sell their ports and needles as a kit while a majority of...