INTERA REFILL KIT

Description of Event or Problem

INTERA ONCOLOGY WAS NOTIFIED THAT A NURSE NOTED FLOXURIDINE LEAKED ON A PATIENT DURING A REFILL PROCEDURE. THE NURSE NOTICED LEAKING FLOXURIDINE WHEN ATTEMPTING TO FLUSH THE LINE FROM EITHER A HOLE IN THE TUBING OR WHERE THE STOPCOCK CONNECTS TO THE PATIENT BELOW THEIR CLOSED SYSTEM TRANSFER DEVICE. INTERA WAS TOLD THAT IT WAS NOT LEAKING PRIOR TO PLACING THE STOPCOCK ON. THE PATIENT'S ABDOMEN WAS CLEANED WITH SOAP AND WATER, AND THERE WAS NO REPORT OF ERYTHEMA, PRURITUS, OR BURNING OF THE SKIN. THE PATIENT AND NURSE WERE NOT WEARING N95'S OR RESPIRATORS BUT NEITHER EXPERIENCED SHORTNESS OF BREATH, WHEEZING, OR BURNING OF THE MOUTH OR NOSE. THE TUBING, SYRINGE, AND ALL REFILL MATERIALS WERE THROWN AWAY DURING THE DECONTAMINATION OF THE ROOM; HOWEVER, THERE WERE TWO PICTURES TAKEN.

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. AS PREVIOUSLY MENTIONED, THE CLINIC PROVIDED US WITH PHOTO EVIDENCE OF THE LEAK. ONE OF THE PHOTOS SHOW A BREAK IN THE TUBING. INTERA ONCOLOGY REPORTED THIS FINDING TO OUR SUPPLIER TO INVESTIGATE. AS OF TODAY, WE'RE WAITING FOR A RESPONSE FROM THE SUPPLIER. THEREFORE, ONCE WE HEAR BACK FROM THE SUPPLIER A SUPPLEMENTAL REPORT WILL BE SUBMITTED.