NRFIT

Additional Manufacturer Narrative

THE FOLLOWING FIELD WAS UPDATED WITH CORRECTIONS: D4. PRIMARY UDI NUMBER: (B)(4). INVESTIGATION SUMMARY: THREE PICTURES WERE ATTACHED TO THE COMPLAINT. ONE SAMPLE OF THE PART NUMBER 21-7609-24 WAS RECEIVED FOR EVALUATION IN UNUSED CONDITION, IN A PLASTIC BAG. DURING VISUAL INSPECTION OF THE DEVICE, NO DISCREPANCIES WERE DETECTED. IT WAS COMPARED WITH A NORMAL SAMPLE AND THE SIZE OF THE MEDICATION BAG IS FINE. DURING THE FUNCTIONAL TESTING OF THE DEVICE RECEIVED, NO DISCREPANCIES WERE DETECTED IN THE MEDICATION BAG. ACCORDING TO SAMPLE RECEIVED, THE FAILURE MODE ¿DIFFICULTY FILLING BAGS¿ WAS NOT CONFIRMED IN THE DEVICE RECEIVED. NO ROOT CAUSE DETERMINED BECAUSE NO PROBLEM WAS FOUND. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

Additional Manufacturer Narrative

B3: DAY OF EVENT IS UNKNOWN. DEVICE EVALUATION: ONE SAMPLE WAS RETURNED IN UNUSED CONDITION. DURING THE VISUAL INSPECTION, NO DISCREPANCIES WERE DETECTED. IT WAS A COMPARED WITH A NORMAL SAMPLE AND THE SIZE OF THE MEDICATION BAG IS FINE. DURING THE FUNCTIONAL TESTING OF THE DEVICE RECEIVED, NO DISCREPANCIES WERE DETECTED IN THE MEDICATION BAG. ACCORDING TO SAMPLE RECEIVED, THE FAILURE MODE ¿DIFFICULTY FILLING BAGS¿ WAS NOT CONFIRMED IN THE DEVICE RECEIVED.

Description of Event or Problem

IT WAS REPORTED THAT THE "BAG DOES NOT FIT WELL WHEN CASSETTE IS FILLED WITH CHEMICALS". THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT.