HEMASHIELD PLATINUM

Description of Event or Problem

COMPLAINT NUMBER: (B)(4).

Additional Manufacturer Narrative

(10/171) THE INVOLVED DEVICE WAS VISUALLY INSPECTED BY THE QUALITY ASSURANCE (QA) ENGINEER AND NO CONCLUSION COULD BE ESTABLISHED DUE TO THE ABSENCE OF AN INTACT PRIMARY SEAL WHICH PREVENTS A DEFINITIVE DETERMINATION OF THE ROOT CAUSE OF THE REPORTED DEFECT. AS THE EXTERNAL SEAL (SHELL AND OUTER LID) WAS COMPLETELY REMOVED BY THE CUSTOMER, IT IS NOT POSSIBLE TO ESTABLISH WITH CERTAINTY WHETHER THE OPENING OF THE INNER LID RESULTED FROM A MANUFACTURING NON-CONFORMITY OR FROM DAMAGE OCCURRING AFTER PRODUCTION. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS ON THE SAME PRODUCT FAMILY (HEMASHIELD GRAFTS AND PATCHES) FOR THE PERIOD 01-DEC-2024 TO 30-NOV-2025. THE CALCULATED OCCURRENCE RATE IS (B)(4), WHICH IS COMPLIANT WITH THE REQUIREMENT OF BEING LESS THAN OR EQUAL TO THE ANTICIPATED MAXIMUM OCCURRENCE RATE OF (B)(4). (4315/25) BASED ON THE INVESTIGATION FINDINGS IT IS CONCLUDED THAT THE ABSENCE OF AN INTACT PRIMARY SEAL PREVENTS A DEFINITIVE DETERMINATION OF THE ROOT CAUSE OF THE REPORTED DEFECT. AS THE EXTERNAL SEAL (SHELL AND OUTER LID) WAS COMPLETELY REMOVED BY THE CUSTOMER, IT IS NOT POSSIBLE TO ESTABLISH WITH CERTAINTY WHETHER THE OPENING OF THE INNER LID RESULTED FROM A MANUFACTURING NON-CONFORMITY OR FROM DAMAGE OCCURRING AFTER PRODUCTION.HOWEVER, THE PRODUCT¿S MANUFACTURING HISTORY INDICATES THAT THE PACKAGING WAS REPROCESSED. THEREFORE, A POTENTIAL FAILURE DURING THIS RECONDITIONING STAGE CANNOT BE RULED OUT. ON THIS BASIS, AN INTERNAL NON-CONFORMITY REPORT WAS OPENED TO FURTHER INVESTIGATE THE POSSIBLE CAUSES AND TAKE APPROPRIATE ACTIONS, IF NECESSARY.

Additional Manufacturer Narrative

(10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 22J07. (3331/3233) A REVIEW OF THE DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT WHEN THE DOCTOR OPEN THE PACKAGE, HE FOUND THE STERILIZED PACKAGE HAS BEEN OPENED. ANOTHER GRAFT WAS USED TO COMPLETE THE SURGERY. COMPLAINT # (B)(4)