BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 15871413 · Received November 28, 2022

    Report

    Report Number
    3002806818-2022-00025
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 28, 2022
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEEDLE BROKE DURING INJECTION BY A NURSE. A REVIEW OF PRODUCTION RECORDS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 211488. A RESISTANCE TO BREAKAGE TEST WAS COMPLETED ON 5 SAMPLES RETAINED FROM THE SAME BATCH. ACCORDING TO ISO 9626. ALL SAMPLES PASSED THE TEST, NO BREAKAGE CAN BE FOUND.

    Description of Event or Problem · 0

    THE NURSE FOUND THAT THE NEEDLE HAS BROKEN OFF DURING PRIMING. THE BROKEN NEEDLE WAS REPLACED TO COMPLETE THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743103 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211488-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown