HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VACULAR GRAFT

Additional Manufacturer Narrative

CORRECTED DATA: BLOCK B5: THE EVENT DESCRIPTION HAS BEEN CHANGED FOLLOWING CLARIFICATION OBTAINED DURING THE INVESTIGATION. ADDITIONAL NARRATIVE: (10/170) THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS VISUALLY INSPECTED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR. THE CONCLUSION IS AS FOLLOWS: "THE DISCREPANCY IS CONFIRMED, THE PROSTHESIS HAS YELLOW BLOTS. THESE BLOTS ARE SIMILAR TO COLLAGEN EXCESSES. THIS DEFECT IS AN AESTHETIC DEFECT. I CAN CONFIRM THAT AS IT STANDS THE PRODUCT SHOULD HAVE BEEN DECLARED NON-COMPLIANT." (143) 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

SEE INITIAL MFR REPORT #1640201-2020-00003. COMPLAINT # (B)(4) CORRECTED DATA: FOLLOWING CLARIFICATION, THE EVENT IS DESCRIBED AS FOLLOWS: WHEN THE CUSTOMER OPENED THE PRODUCT, THEY FOUND THERE WAS YELLOW BLOT ON SURFACE OF THE GRAFT.

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. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

(B)(4). WHEN THE CUSTOMER OPENED THE PRODUCT, HE FOUND YELLOW BLOT ON THE INNER PACKAGE OF THE GRAFT. IT OCCURRED BEFORE THE SURGERY. AS WE KNOW, THE SURGERY DID NOT DELAY.