HEMASHIELD PLATINIUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME STERILIZATION LOT . THE DEVICE HISTORY RECORDS REVIEW CONCLUDES THAT THERE IS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS VISUALLY INSPECTED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR. RESULTS ARE AS FOLLOWS: "THE DISCREPANCY IS CONFIRMED, THE GRAFT PRESENTS YELLOW STAINS.¿ ¿THESE STAINS ARE SIMILAR TO EXCESSES OF COLLAGEN WHICH ARE ROUTINELY ACCEPTED ACCORDING TO ACCEPTANCE CRITERIA DEFINED IN [THE INTERNAL LIST OF STANDARDS FOR ACCEPTATION AND REJECTION AT QC STEP]. THIS DEFECT IS A COSMETIC DEFECT. WE HAVE REVIEWED THE GRAFT WITH [A LEAD OP ], WE CONFIRM THAT IN ITS STATE THE PRODUCT SHOULD HAVE BEEN DECLARED NON-COMPLIANT, THE NON-COMPLIANCE OF THE PROSTHESIS OF THE COMPLAINT COMES FROM THE FACT THAT THERE ARE SEVERAL EXCESSES. " THE OUTCOME OF THE INVESTIGATION WOULD TEND TO INDICATE THAT THE ISSUE IS RELATED TO A PRESENCE OF COLLAGEN EXCESSES WHICH SHOULD HAVE BEEN REJECTED DURING THE 100% VISUAL INSPECTION. THEREFORE, A 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 OPENED THE PACKAGE, THEY FOUND SOME YELLOW BLOTS ON THE SURFACE OF THE GRAFT. (B)(4).