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. ON FEBRUARY 6, 2026, INTERA ONCOLOGY SHIPPED A RETURN KIT TO THE CLINIC TO RETRIEVE THE DEVICE FOR EXAMINATION. TO DATE, THE KIT HAS NOT BEEN RETURNED. THEREFORE, ONCE WE RECEIVE THE REFILL KIT AND IT'S EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED BY A NURSE THAT A REFILL KIT LEAKED FLOXURIDINE (FUDR). THE CLINIC SAVED THE TUBING AND PROVIDED US WITH PHOTOS OF THE PRODUCT LABELING. THE NURSE CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTION. FUDR DID NOT LEAK ONTO THE PATIENT. ACCORDING TO THE NURSE, THE LEAK HAPPENED WHERE THE TUBE CONNECTS TO THE HUB. THE DEVICE HAS NOT BEEN SHIPPED.

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED BY A NURSE THAT A REFILL KIT LEAKED FLOXURIDINE. THE CLINIC SAVED THE TUBING AND PROVIDED US WITH PHOTOS OF THE PRODUCT LABELING. THE NURSE CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTION. FLOXURIDINE DID NOT LEAK ONTO THE PATIENT. ACCORDING TO THE NURSE, THE LEAK HAPPENED WHERE THE TUBE CONNECTS TO THE HUB. THE DEVICE HAS NOT BEEN SHIPPED.

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. THE TUBING SET WAS NOT REMOVED OUT OF THE PACKAGING DUE TO THE CLINIC NOT DISPOSING FLOXURIDINE OUT OF THE TUBING. HOWEVER, THE DEVICE WAS EVALUATED AND THERE WERE NO VISUAL DEFECTS NOTED.