POOLE

Description of Event or Problem

DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

AN EXAMINATION OF RETURNED UNUSED DEVICE (B)(4) FOUND THAT THERE WAS AN INSUFFICIENT HEAT-SEAL. DYE LEAK TEST WAS NOT NEEDED AS THE INSUFFICIENT SEAL WAS VISUALLY OBSERVABLE ON BOTH DEVICES. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON EVALUATION OF THE DEVICE, A POSSIBLE CAUSE OF THIS EVENT IS THE DEVICE WAS ENCROACHING INTO 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 TWO (2) DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 43 REPORTS, REGARDING 129 DEVICES, 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). WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.