HEMASHIELD GOLD KNITTED

Description of Event or Problem

SURGEON IMPLANTED CONSIGNED GRAFT THAT WAS EXPIRED INTO PATIENT.

Additional Manufacturer Narrative

ADDITIONAL MANUFACTURER NARRATIVE: AT TIME OF THIS REPORT, NO INJURY INFORMATION WAS COMMUNICATED TO INTERVASCULAR. HOWEVER, IT WAS DECIDED TO CONSIDER, AS CONSERVATIVE APPROACH, THAT THE INVOLVED DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. THE INVESTIGATION INVOLVED COMMUNICATION WITH PERSONS CLOSE TO THE EVENT, E.G. HEALTHCARE PROFESSIONALS (DOCTORS, NURSES ETC.). IN SUMMARY, THEY WERE NOT AWARE THAT THE GRAFT WAS EXPIRED AT THE TIME OF IMPLANTATION, BUT REALIZED IT AFTER THE FACT. THE INITIAL REPORTER DOES NOT THINK THAT THE PATIENT EXPERIENCED ANY COMPLICATIONS. NO OTHER INFORMATION WAS GIVEN. INFORMATION ABOUT THE CONSIGNMENT AND INVENTORY PROCESS (MANAGEMENT AND CONTRACT) IS BEING REQUESTED TO PEOPLE CLOSE TO THE EVENT IN ORDER TO DETERMINE A ROOT CAUSE TO THE REPORTED EVENT. ANSWERS ARE PENDING. (B)(4) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. THE CAUSE OF THE REPORTED EVENT WAS TRACED TO THE USER WHO USED A DEVICE THAT HAS EXCEEDED THE EXPIRATION DATE VALIDATED BY THE MANUFACTURER FOR STORING THE DEVICE WITHOUT A DEGRADATION IN QUALITY AND STERILITY. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

SEE MFG INITIAL REPORT #1640201-2022-00016. COMPLAINT (B)(4).

Additional Manufacturer Narrative

(4112/213) THE CASE WAS REVIEWED BY THE MEDICAL AFFAIRS WHOSE ASSESSMENT IS AS FOLLOWS : "THE EVENT WHICH OPENED THIS COMPLAINT IS THE IMPLANTATION OF A HEMASHIELD GOLD KNITTED GRAFT (M002020952060), SERIAL NUMBER (B)(6), BATCH NUMBER 17A25, WITH AN EXPIRATION DATE OF 31-DEC-2021. THE DEVICE WAS IMPLANTED ON (B)(6) 2022, AND IT IS REPORTED THAT THE EXPIRATION DATE WAS NOT REALIZED UNTIL AFTER THE IMPLANTATION. THE DEVICE REMAINED IMPLANTED, AND THE EVENT WAS REPORTED ON 29-APR-2022 BY THE ACCOUNT. IN FOLLOW UP, THE SALES REPRESENTATIVE ASKED IF THERE WAS ANY CONSEQUENCE TO THE PATIENT AND THE ACCOUNT RESPONDED THAT THEY WERE UNAWARE OF ANY PATIENT COMPLICATIONS DUE TO THE IMPLANTED EXPIRED DEVICE. THE DATA EXISTING ON THE DEVICE IS AVAILABLE ONLY UNTIL THE DATE OF EXPIRATION - THERE IS NO DATA ON THE INTEGRITY OF THE STERILE BARRIER OR PERFORMANCE OF THE DEVICE AFTER THE EXPIRATION DATE. HOWEVER, THERE ARE NO KNOWN CONCERNS REGARDING THE MECHANICAL INTEGRITY OF THE DEVICE ONCE IT IS IMPLANTED. FROM THE PROCEDURE DATE UNTIL THE DATE THE COMPLAINT WAS FILED, THE PATIENT DID NOT APPEAR TO HAVE ANY CLINICAL CONSEQUENCES. MEDICAL AFFAIRS REQUESTS THAT THE COMPLAINT BE UPDATED WITH THE NAME OF THE SURGEON (INCLUDING CONTACT INFORMATION) AND HOSPITAL WHERE THE PROCEDURE WAS PERFORMED. ONCE THIS INFORMATION IS RECEIVED, MEDICAL AFFAIRS WILL ATTEMPT TO CONTACT THE SURGEON AND OBTAIN ADDITIONAL INFORMATION REGARDING THE SURGICAL PROCEDURE AND PATIENT STATUS, AND THIS MEDICAL REVIEW WILL BE UPDATED. ADDENDUM: THE REQUEST FOR THE SURGEON NAME, CONTACT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE PATIENT¿S STATUS HAS BEEN DENIED. AS SUCH, NO FURTHER COMMENT OR CONCLUSION CAN BE MADE PERTAINING TO THIS INCIDENT. IT IS MAINTAINED THAT THE PATIENT HAS NOT APPEARED TO SUFFER ANY CLINICAL CONSEQUENCE AND THERE ARE NO KNOWN CONCERNS REGARDING THE MECHANICAL INTEGRITY OF THE DEVICE." (B)(4). (4111/4248) INFORMATION ABOUT THE CONSIGNMENT AND INVENTORY PROCESS (MANAGEMENT AND CONTRACT) HAS BEEN REQUESTED TO PEOPLE CLOSE TO THE EVENT IN ORDER TO DETERMINE A ROOT CAUSE TO THE REPORTED EVENT. IT WAS REPORTED TO US THAT THE SALES AND SERVICE UNIT PROVIDES DEVICES TO THE HOSPITAL. AS PRODUCT IS USED, HOSPITAL PAYS FOR USED INVENTORY. HOWEVER, THE HOSPITAL IS RESPONSIBLE FOR MANAGING THE DAY TO DAY INVENTORY. THE SALES REPRESENTATIVE DOES CHECK INVENTORY ON A BI-ANNUAL BASIS FOR ACCURACY AND PROPER PRODUCT MIX. FOLLOWING THE CASE, THE STOCK HAS BEEN CHECKED BY THE SALES REPRESENTATIVE IN CHARGE AND ARE ALL IN DATE. IT WAS CONFIRMED THAT THE PREVIOUS CHECK PERFORMED WAS NOT EFFICIENT ENOUGH AS IT DID NOT ALLOW TO IDENTIFY THE OUT-OF-DATE BOX. THE SALES REP WHO WAS AT THE TIME RESPONSIBLE FOR IT LEFT THE COMPANY SINCE. THE ROOT CAUSE IS DUE TO A HUMAN ERROR LINKED TO A FAILURE OF THE CONSIGNMENT CHECK PROCESS. FOLLOWING THE CASE, THE STOCK HAS BEEN CHECKED BY THE NEW SALES REPRESENTATIVE IN CHARGE AND BOXES ARE ALL UP-TO DATE. (19) BASED ON THE INFORMATION PROVIDED BY THE SALES REPRESENTATIVE ,WE CONCLUDE THAT THE EVENT IS ISOLATED. A PREVENTIVE ACTION HAS BEEN IMPLEMENTED TO STRENGTHEN THE PROCESS (QUARTERLY CHECK BY THE NEW SALES REP INSTEAD OF EVERY 6 MONTHS) NEVERTHELESS, THE HOSPITAL STILL HAS THE RESPONSIBILITY TO VERIFY THE DATE OF THE PRODUCT PRIOR USE AND TO APPLY THE FIFO PRINCIPLE. AS A SENSIBILIZATION ACTION, A LETTER WILL BE SENT TO THE HOSPITAL IN THAT SENSE.