HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

CORRECTED DATA: BLOCK D4: THERE WAS AN ERROR IN THE EXPIRY DATE IN THE INITIAL REPORT, IT IS 31 MAY 2026. BLOCK E2 AND E3: THERE WAS AN ERROR IN THE INITIAL REPORT, THE INITIAL REPORTER IS NOT A HEALTH PROFESSIONAL, IT IS A DISTRIBUTOR. BLOCK G2: THERE WAS AN ERROR IN THE REPORT SOURCE, THE REPORT WAS COMING FROM A DISTRIBUTOR. WE APOLOGIZE FOR THESE ERRORS. ADDITIONAL NARRATIVE: (10/3236) THE RETURNED DEVICE WAS VISUALLY INSPECTED BY THE QA SUPERVISOR WHO CONFIRMED THAT THE SHIPPING BOX WAS DAMAGED AND THE PRODUCT BOX WAS DAMAGED. AS A RESULT, PRODUCT IS NOT COMPLIANT. FOLLOWING THIS VISUAL INSPECTION, THE QA MANAGER CONCLUDED ON THE ROOT CAUSE OF THE EVENT: "IT IS A PROBLEM DUE TO THE TRANSPORTATION." (4308) THE MOST LIKELY CAUSE OF THIS EVENT IS A PROBLEM DUE TO THE TRANSPORTATION. AN INTERNAL NON-CONFORMITY REPORT HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTION.

Description of Event or Problem

SEE MFG INITIAL REPORT 1640201-2021-00028. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 21F02. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THIS IS A CASE OF A PRODUCT DAMAGED DURING TRANSPORTATION. THE PRODUCT WAS DAMAGED WHEN IT ARRIVED AT THE END CUSTOMER. SHIPMENT WAS REJECTED BY THE CUSTOMER BECAUSE THE SHIPMENT BOX WAS WET AND DAMAGED.