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 BREAK AND LEAK. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE.

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN ASSISTANT THAT ON (B)(6) 2025, THAT THEY NOTICED THAT THE END THAT'S CONNECTED TO THE TUBING SET WAS CRACKED WHICH CAUSED FLOXURIDINE (FUDR) TO LEAK DURING THE REFILL PROCEDURE. UPON THE LEAK, THEY ABORTED THE REFILL PROCEDURE, REMOVE THE NEEDLE FROM THE PUMP AND OPENED UP A NEW REFILL KIT AND SUCCESSFULLY REFILLED THE PUMP WITHOUT ANY ISSUES. DURING FOLLOW-UP COMMUNICATION WITH THE CLINIC, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCED AN ADVERSE REACTION AND ONLY EXPERIENCED DELAY IN TREATMENT. THE SAMPLE WAS DISCARDED DUE TO FUDR BEING IN THE LINE. THEY DON'T KNOW HOW THE TUBING BROKE. THE EXACT LOCATION OF THE BREAK WAS WHERE THE PVC TUBING IS ATTACHED TO THE HUB AT THE END. THE CLINIC ONLY PROVIDED US WITH PHOTOS THAT SHOWS THE PACKAGING OF THE TUBING.