SINGLE FUNCTION HNDPC ABC ELEC

Additional Manufacturer Narrative

TWO 130344 WERE RECEIVED IN UNOPENED ORIGINAL PACKAGING, THE REPORTED CATALOG AND LOT NUMBERS WERE VERIFIED. VISUAL INSPECTION FOUND NO OBVIOUS SIGNS OF ABNORMALITIES OR DEFECTS. THE DEVICE WAS DYE LEAK TESTED. TESTING FINDING THERE WAS NOT A BREACH WITHIN THE STERILE BARRIER. 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. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 5 COMPLAINTS, REGARDING 75 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 200,250 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 0.0004. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONTRAINDICATIONS: THESE DEVICES SHOULD NEVER BE USED WHEN: -THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE, SUCH AS DUCTS, PUNCTURES, NICKS ABRASIONS, UNUSUAL LUMPS OR SIGNIFICANT DISCOLORATION. INSPECTION: THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICE FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: -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.

Additional Manufacturer Narrative

THE REPORTED DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE PRODUCT EVALUATION AND THE COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE 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. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.