HEMASHIELD PLATINUM WOVEN

Description of Event or Problem

SEE MFG REPORT(S) # 1640201-2021-00026. COMPLAINT #(B)(4).

Additional Manufacturer Narrative

A RECALL WAS INITIATED ON (B)(6) 2022 TO WITHDRAW TWO INVERTED PRODUCTS FROM THE MARKET. ONE MISLABELED PRODUCT IS LOCATED IN THE US (CORRESPONDING TO COMPLAINT #(B)(4). MFG REPORT NUMBER 1640201-2021-00034). ONE MISLABELED PRODUCT IS LOCATED IN CHINA (CORRESPONDING TO THIS COMPLAINT #(B)(4) - MFG REPORT NUMBER 1640201-2021-00026).

Additional Manufacturer Narrative

OCCUPATION, THE VALUE WAS LEFT BLANK BECAUSE THE NAME OF THE INITIAL REPORTER AND HIS OCCUPATION ARE UNKNOWN. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER (20M16) (3331/4245) A REVIEW OF MANUFACTURING RECORDS (MFG OPERATIONS TRACEABILITY) ALLOWED US TO MAKE THE ASSUMPTION THAT A POSSIBLE INVERSION OCCURRED AT THE PRIMARY PACKAGING STEP BETWEEN PRODUCT REF (B)(4) (LOT 20M16, SN(B)(4)) AND PRODUCT REF (B)(4) (LOT 20M16, SN(B)(4)), LEADING TO A MISLABELING OF BOTH PRODUCTS. AS REQUESTED IN THE PRODUCT NON-CONFORMITY REPORT OPENED FOR THIS ISSUE, A HEALTH HAZARD EVALUATION (HHE) HAS BEEN INITIATED CONCERNING THE SECOND PRODUCT INVOLVED BY THE ISSUE. (10/4245) THE COMPLAINT RETURNED PRODUCT WAS INSPECTED. THE CONCLUSION CONFIRMED THAT THE PRODUCT BLISTER INSIDE THE BOX DOES NOT MATCH THE IDENTIFICATION OF THE BOX, THE IDENTIFICATION OF THE PATIENT LABEL SET AND THE IDENTIFICATION OF THE GRAFT SIZERS. (25) THE CONDUCTED INVESTIGATION CONCLUDED THAT THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT CONFORM DUE TO A PRODUCT MISLABELING OCCURRING BECAUSE INSTRUCTIONS WERE NOT STRICTLY FOLLOWED AT PRIMARY PACKAGING AND FINAL PACKAGING CHECK STEPS. A CAPA HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTIONS.

Description of Event or Problem

CUSTOMER COMPLAINT #(B)(4) WAS MENTIONING A MISLABELING AS DESCRIBED BELOW: WHEN THE BOX WAS OPENED BEFORE USE FOR THE PATIENT, IT WAS CONFIRMED THAT A DIFFERENT PRODUCT WAS PACKAGED. LABEL ON THE BOX IS REF (B)(4) (LOT 20M16, SN(B)(4)), BUT THE ACTUAL PRODUCT INSIDE WAS REF (B)(4) (LOT 20M16, SN1(B)(4)). THE PRODUCT WAS RETURNED BACK TO THE DISTRIBUTOR FROM END USER SITE. WE HAVE RECEIVED CONFIRMATION THAT NO PATIENT WAS HARMED BY THE INCIDENT.