BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVICEL DEVICE 1ML/2ML

    MDR report key: 15045922 · Received July 18, 2022

    Report

    Report Number
    3003183625-2022-00005
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    October 26, 2022
    Manufacturer
    TEL-HASHOMER
    Product Code
    MZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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: WAS THERE ANY QUALITY ISSUE IN REGARDS TO THE BIOLOGIC VIALS? IF YES, PLEASE CLARIFY WHAT WAS THE QUALITY ISSUE EXPERIENCED WITH THE BIOLOGICS? NO. THE QUALITY ISSUE IS FOR THE DEVICE CONNECTOR BEING BROKEN. 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). H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE LEFT SIDE CONTAINER COULD NOT BE ASSEMBLED, AND THE TIP OF THE CONNECTOR WAS BROKEN. ACCORDING TO THE MANUFACTURER, IT IS ESTIMATED THAT THE USER ROTATED THE VIAL HOLDER WITH FORCE, AS A RESULT THE HUBS BROKE AND THE CORE WAS FOUND IN INCORRECT POSITION. WHEN THE EVALUATOR RETURNED THE CORE TO THE CORRECT POSITION AND ASSEMBLED A NEW VIAL HOLDER THE DEVICE WORK PROPERLY. NO PROBLEM WAS FOUND ON THE DEVICE WHEN TESTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. DURING PREPARATION THE LEFT SIDE CONTAINER COULDN¿T BE ASSEMBLED AND THE TIP OF THE CONNECT WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456779 EVICEL DEVICE 1ML/2ML FIBRIN SEALANT PREPARATION DEVICE MZM TEL-HASHOMER 210055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown