NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X0.897 STERILE

Description of Event or Problem

COMPLAINANT ALLEGES "I HAVE A PRODUCT FAILURE THAT WAS REPORTED TO ME TODAY BY SURGERY. THIS WAS ALSO REPORTED TO THE RISK MANAGEMENT TEAM DUE TOP PATIENT INVOLVEMENT. "AFTER SECOND COUNT, SURGEON REQUESTED FREE NEEDLE AT THE STERILE FIELD AND SURGEON NOTICED THAT THERE WAS NO SUTURE THREADED THROUGH THE EYE OF THE NEEDLE. MAGNET USED TO ATTEMPT TO FIND PORTION OF NEEDLE ON THE FLOOR. DRAINED UNDER BUTTOCK DRAPE POUCH INTO CONTAINER AND LOOKED THROUGH BY STAFF. X-RAY PERFORMED AT COMPLETION OF SURGERY PER POLICY AND NO EVIDENCE OF MISSION PORTION OF NEEDLE WAS NOTED IN PATIENT. INCIDENT REPORT FILED. FINAL COUNT NOTED TO BE INCORRECT DUE TO PORTION OF NEEDLE MISSING AND NOT ACCOUNTED FOR."

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.