BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVICEL DEVICE 1ML/2ML

    MDR report key: 11722099 · Received April 25, 2021

    Report

    Report Number
    3003183625-2021-00003
    Event Type
    Malfunction
    Date Received
    April 25, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 2, 2021
    Manufacturer
    TEL-HASHOMER
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/27/2021. INVESTIGATION SUMMARY VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. PERFORM VISUAL INSPECTION: THE DEVICE ARRIVED BROKEN. PERFORM FUNCTIONALITY TEST ON DEVICE AS IT WAS RETURNED: - STATE IF THE MIXJECT VALVES WERE IN THE CORRECT OR INCORRECT POSITION WHEN EXAMINING: THE CORES WERE NOT IN CORRECT POSITION. - STATE IF THE MIXJECT CORES WERE ASSEMBLED IN THE CORRECT OR INCORRECT POSITION DURING PRODUCTION: THE CORES WERE ASSEMBLED CORRECTLY DURING THE PRODUCTION. - CAN DRAWING BE PERFORMED? NO PERFORM FUNCTIONALITY TEST WITH WATER AFTER CORRECTION/REPLACEMENT OF THE FAILURE SOURCE AND PROVE THAT THE DEVICE FUNCTIONS CORRECTLY: - IF THE MIXJECT VALVES ARE NOT IN THE CORRECT POSITION, PUT THEM INTO CORRECT POSITION AND PROVE DEVICE FUNCTIONS CORRECTLY WHEN SET UP CORRECTLY: NO WAY TO PERFORM ANY TEST ON DEVICE IN THE WAY IT WAS RECEIVED. CONCLUSION: USER FAILURE. IT IS NOT CLEAR TO US HOW THE CUSTOMER TRIED TO USE THE DEVICE. DUE TO THE BROKEN DEVICE, NO TESTING COULD BE PERFORMED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: CAN YOU IDENTIFY THE LOT NUMBER OF THE DEVICE? UNKNOWN. CAN YOU IDENTIFY THE LOT NUMBER OF THE EVICEL APPLICATION DEVICE? UNKNOWN. WAS THERE ANY PATIENT CONSEQUENCE? IF SO, WAS THERE ANY ASSOCIATED MEDICAL OR SURGICAL INTERVENTION? THERE WERE NO PATIENT CONSEQUENCES NOR CONCOMITANT MEDICAL AND SURGICAL INTERVENTIONS CARRIED OUT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WILL THE APPLICATION DEVICE BE RETURNED FOR EVALUATION? INVESTIGATION SUMMARY: ACCORDING TO THE PHOTO ONE OF THE DEVICE'S VIAL HOLDER PERFORATOR WAS BROKEN AND SEPARATED. IT IS DIFFICULT TO INDICATE WHAT IS THE CAUSE FOR THIS DEFECT - 2 SCENARIOS ARE POSSIBLE: THE BIOLOGICS VIAL RUBBER STOPPER CAUSED THIS DEFECT OR THE VIAL HOLDER WAS TOO WEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. WHEN REPLACING THE STANDARD TIP WITH A HARD ADDITIONAL TIP, ONE OF THE FIXING "SCREWS" BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618375 EVICEL DEVICE 1ML/2ML FIBRIN SEALANT PREPARATION DEVICE MZM TEL-HASHOMER

    Patients

    Seq Age Sex Outcome Treatment
    1