HAWKINS III FLEXSTRAND BLN 20GA X 12.5CM

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

Description of Event or Problem

"WHEN WE PARK THE ANGLER WIRE IN THE PATIENT & REMOVED THE NEEDLE IN THE PATIENT, THE WIRE WAS STUCK INSIDE THE NEEDLE AND CARRIED OUT WITH THE NEEDLE." MEDICAL INTERVENTION WAS REQUIRED.

Additional Manufacturer Narrative

WE HAVE CAREFULLY REVIEWED THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT AND FOUND NO DEVIATIONS OR NON-CONFORMANCES. EVERYTHING MEETS OUR HIGH STANDARDS OF QUALITY. DESPITE MULTIPLE REQUESTS, WE HAVE NOT YET RECEIVED THE SAMPLE RELATED TO THE COMPLAINT. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE HAS BEEN PROVIDED TO SUPPORT A REVIEW OF THE CONCERN. WITHOUT THIS NECESSARY INFORMATION, A THOROUGH INVESTIGATION CANNOT BE CONDUCTED, AND IDENTIFYING A ROOT CAUSE OR CORRECTIVE ACTION IS NOT FEASIBLE. AT THIS TIME, NO CORRECTIVE ACTION IS REQUIRED. HOWEVER, IF THE SAMPLES ARE PROVIDED AT A LATER DATE, WE WOULD BE HAPPY TO REOPEN THE COMPLAINT FOR FURTHER EVALUATION. ADDITIONAL INFORMATION PROVIDED IN H6 AND H11.