POOLE

Additional Manufacturer Narrative

PERFORMED A VISUAL INSPECTION OF THE DEVICES, THERE WERE NO OBVIOUS SIGNS OF A BREACH. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD INSUFFICIENT HEAT SEAL ON ONE OF THE PACKAGES AS THERE WAS LEAKAGE. THE SECOND DEVICE DID NOT HAVE LEAKAGE. 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 2 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 37 REPORTS, REGARDING (B)(4) 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.

Description of Event or Problem

UPDATE 19FEB25: THE DEVICE WAS RETURNED AND EVALUATED. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT HAS BEEN REASSESSED AND MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. THE DISTRIBUTOR REPORTED THAT THE 0035040 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME.