HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

(10/4245) THE DEVICE INVOLVED IN THE COMPLAINT WAS RETURNED TO THE MANUFACTURER AND WAS INSPECTED BY THE QUALITY ASSURANCE (QA) SUPERVISOR FOR AN EVALUATION OF THE PACKAGING COMPONENTS. MAIN ELEMENTS OF HER OBSERVATIONS ARE AS FOLLOWS: THERE IS A MATCH BETWEEN THE LABELING OF THE OPEN EXTERNAL PACKAGING, PATIENT SET AND GRAFTS SIZERS (PRODUCT REFERENCE: (B)(4), 1-BRANCH AORTIC ARCH, SERIAL NUMBER: 1314389316 LOT NUMBER: 21A27) HOWEVER, THE PRODUCT CONTAINED IN THE PRIMARY PACKAGING AND ITS LABELING (PRODUCT REFERENCE: (B)(4), 4-BRANCH AORTIC ARCH, SERIAL NUMBER: (B)(6), LOT NUMBER: 21A27) DOES NOT CORRESPOND TO THE EXTERNAL BOX LABELING. THE PRODUCT INSIDE THE BOX IS A 4-BRANCH AORTIC ARCH. THEREFORE, THE NON-CONFORMITY IS CONFIRMED, AND FOLLOWING THE ERROR THAT OCCURRED, THE PRODUCT IDENTIFIED ON THE BOX AS PRODUCT REFERENCE: (B)(4) (4-BRANCH AORTIC ARCH), SERIAL NUMBER: (B)(6), LOT NUMBER: 21A27 SHOULD CONTAIN A 1-BRANCH PRODUCT. AS REQUESTED IN THE PRODUCT NON-CONFORMITY REPORT, A CAPA (#TW480114) AND A HEALTH HAZARD EVALUATION (HHE) HAVE BEEN INITIATED. FOLLOWING THIS EVALUATION, A RECALL WAS INITIATED TO WITHDRAW THE SUSPECT PRODUCT FROM THE MARKET. PLEASE NOTE THAT ONLY 1 (ONE) DEVICE IS INVOLVED AND IT IS LOCATED IN CHINA. THERE IS NO DEVICE INVOLVED IN THE USA. (25) IN CONCLUSION, THE CONDUCTED INVESTIGATION INDICATED 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. IT WAS DECIDED TO WITHDRAW THE SECOND PRODUCT INVOLVED FROM THE MARKET. A CAPA HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTIONS.

Description of Event or Problem

SEE INITIAL MFR REPORT 1640201-2021-00019. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

PICTURES OF THE INNER PACKAGING (PRODUCT BLISTER) AND OUTER PACKAGING (BOX) WERE PROVIDED, SHOWING EVIDENCE OF INACCURATE LABELING. INDEED, IT APPEARS ON THE PICTURES THAT THE OUTER PACKAGING (BOX) OF THE INVOLVED PRODUCT IS LABELED AS HEMASHIELD PLATINUM WITH A DRAWING 1-BRANCH, D: 30 X10 MM, LOT 21A27, SN (B)(4) AND IT APPEARS ON THE PICTURES THAT THE BLISTER PACK IS LABELED AS HEMASHIELD PLATINUM WITH A DRAWING 4-BRANCH, D: 24 X 10X 8 X 8 X 10 MM, LOT 21A27, SN (B)(4). A PRODUCT NON-CONFORMITY REPORT WAS OPENED IN ORDER TO TAKE APPROPRIATE ACTIONS. (3331/4245) AFTER REVIEW OF MANUFACTURING RECORDS AND DISCUSSION WITH PRODUCTION SUPERVISOR, THE MOST LIKELY CAUSE OF THIS EVENT IS THAT AN ERROR OCCURRED DURING THE PRIMARY PACKAGING OPERATION. THIS ERROR WAS NOT SUBSEQUENTLY DETECTED DURING THE FINAL PACKAGING OPERATION. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER (21A27) IT WAS REPORTED THAT THE INVOLVED PRODUCT IS AVAILABLE FOR INVESTIGATION, IT IS IN TRANSIT TO THE MANUFACTURER. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

CUSTOMER COMPLAINT #(B)(4) WAS MENTIONING A MISLABELING AS DESCRIBED BELOW: OUTER PACKAGING [BOX] MARKED WITH THE WRONG LABEL. OTHER PRODUCT IN STERILE PACKAGING. ON MONDAY 10/5, A PATIENT WAS OPERATED ON AORTIC SURGERY; WHEN THE SELECTED GRAFT WAS OPENED, HEMASHIELD PLATINUM 30 X10MM IS CORRECTLY LABELED ON THE OUTER PACKAGE [BOX], BUT THE WRONG GRAFT IS IN THE INNER PACKAGE: HEMASHIELD PLATINUM 24 X 10 X 8 X 8 X 10 MM. WE HAVE RECEIVED CONFIRMATION THAT THE PATIENT WAS NOT HARMED BY THE INCIDENT.