SINGLE FUNCTION HNDPC ABC ELEC

Additional Manufacturer Narrative

THE REPORTED UNUSED DEVICE WAS RETURNED FOR EVALUATION IN ITS ORIGINAL UNOPENED PACKAGE. LABEL VERIFICATION AND VISUAL INSPECTION WERE PERFORMED. THE COMPLAINT PRODUCT WAS OBSERVED TO HAVE DAMAGE ON THE PACKAGING'S TYVEK MATERIAL. THIS DAMAGE CAUSED A BREACH IN STERILITY. DUE TO THE EXTENT AND APPEARANCE OF THE DAMAGE ON THE OUTSIDE OF THE TYVEK MATERIAL, IT APPEARS THAT THE PRODUCT PACKAGING WAS DAMAGED FROM THE OUTSIDE. IT IS LIKELY THAT THE PACKAGE WAS DAMAGED FROM AN OUTSIDE SOURCE AND THEREFORE NOT LIKELY A MANUFACTURING DEFECT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. OF THE LOT CONTAINING 600 UNITS, NO PRIOR COMPLAINTS HAVE BEEN RECEIVED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED TWO SIMILAR PRIOR COMPLAINTS. DURING THIS SAME TIME FRAME, 31,500 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. A RISK ANALYSIS WAS PERFORMED AND DEEMED ACCEPTABLE. THIS REPORTED PACKAGING ISSUE WAS OBVIOUS TO THE DISTRIBUTOR, PROMPTING THE RETURN OF THE DEVICE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCT OCCURS MULTIPLE TIMES PRIOR TO USE. GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNING. -IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

Description of Event or Problem

THE DISTRIBUTOR IN (B)(4) REPORTED A "TEAR" ON THE STERILE POUCH OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.