INTERA REFILL KIT

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INTERA ONCOLOGY IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT WITHOUT THE ACTUAL SAMPLE OR PHOTO EVIDENCE SHOWING THE LEAK. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE. SECTION A PATIENT INFORMATION WAS REQUESTED AND THE CLINIC DECLINE TO PROVIDE THE INFORMATION.

Description of Event or Problem

A CLINIC INFORMED INTERA ONCOLOGY THAT DURING A REFILL PROCEDURE ON (B)(6) 2026, THEY EXPERIENCED A LEAK FROM THE REFILL KIT. ACCORDING TO THE CLINIC THE NEEDLE WAS SCREWED ON TIGHTLY TO THE TUBING, BUT WHEN FLOXURIDINE WAS PUSHED THROUGH THE TUBING, IT LEAKED FROM THE LUERLOCK BETWEEN THE TUBING AND NEEDLE. THE PATIENT'S SKIN WAS EXPOSED TO FLOXURIDINE. HOWEVER, THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION (EX. SKIN IRRITATION, RASH, ETC). IN ADDITION, THE CLINIC DISCARDED THE SAMPLE, AND NO PICTURE OF THE LEAK WAS TAKEN.