HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NONCONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS PERFORMED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR. A DEFORMATION AT ONE END OF THE GRAFT WAS CONFIRMED AND THE CUTTING WAS NOT REGULAR. IT WAS CONCLUDED THAT THESE DEFECTS WERE PROBABLY DUE TO A HUMAN ERROR DURING MANUFACTURING (TRIMMING PROCESS). THE PRODUCT, AS IT IS, IS NOT CONFORM. THE CONDUCTED INVESTIGATION INDICATES THAT THE DEVICE WAS DEFECTIVE. THE MOST PROBABLE CAUSE IS A TRIMMING PROCESS FAILURE LEADING TO A NON CONFORMING PRODUCT. AN INTERNAL NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO INVESTIGATE THE ROOT CAUSE AND TAKE APPROPRIATE CORRECTIVE ACTIONS IF NECESSARY.

Description of Event or Problem

WHEN THE CUSTOMER OPEN A PACKAGE WITH A GRAFT, THEY FOUND THAT THE SHAPE OF ONE END OF THE GRAFT IS NOT CIRCULAR, BUT PRESSED. THE SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER GRAFT OF THE SAME MODEL. THERE WAS NO PATIENT EFFECT REPORTED. IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THE PRODUCT WAS POSITIONED CORRECTLY IN THE PACKAGING.