ABC

Additional Manufacturer Narrative

RECEIVED ONE OF 130344 IN ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF A BREACH. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICE WAS DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGE HAD AN INSUFFICIENT HEAT SEAL AS THERE WAS A LEAK. A ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BASED UPON EVALUATION OF THE DEVICE, A POSSIBLE CAUSE OF THIS EVENT COULD BE THE DEVICE WAS ENCROACHING THE SEAL. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF ONE DEVICE FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 1 COMPLAINT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT THESE DEVICES SHOULD BE INSPECTED BEFORE USE WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

Description of Event or Problem

DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 130344, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.