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Patient 1
THE REPORTED UNUSED DEVICES WERE RETURNED FOR EVALUATION IN THEIR ORIGINAL UNOPENED PACKAGE. LABEL VERIFICATION AND VISUAL INSPECTION WERE PERFORMED. VISUAL INSPECTION OF THE DEVICES FOUND A HOLE IN THE PACKAGING OF THE DEVICE WHICH CAUSED A BREACH IN STERILITY. THE LOCATION OF THE HOLE WAS NEAR THE SEAL AREA ON THE INNER SIDE. THE LOCATION OF THE HOLE WAS NOT NEAR ANY FEATURE OF THE DEVICES THAT ARE LIKELY TO CAUSE A HOLE; THEREFORE, IT IS LIKELY THAT THIS HOLE WAS CAUSED FROM THE OUTSIDE OF THE PACKAGING INWARD. 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 WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE (B)(4). A (B)(4) REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) COMPLAINTS, 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). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: THESE DEVICE SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF YOU FIND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS, BROKEN OR SIGNIFICANTLY BENT HANDLE, SHAFT OR CONNECTOR CONTACTS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.