BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 15760420 · Received November 9, 2022

    Report

    Report Number
    3002806818-2022-00024
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 9, 2022
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NEEDLE BROKE DURING INJECTION. A REVIEW OF PRODUCTION RECORDS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 201098. A RESISTANCE TO BREAKAGE TEST WAS COMPLETED ON 5 SAMPLES 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 NEEDLE BROKE OFF DURING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432170 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 201098-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown