BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7ER

    MDR report key: 20043050 · Received August 22, 2024

    Report

    Report Number
    3002806818-2024-00021
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 22, 2024
    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

    DURING NEEDLE REPLACEMENT, THE NEEDLE CANNULA WAS FOUND TO BE BROKEN. NO OTHER INFORMATION WAS PROVIDED AS WELL AS WHETHER THE CANNULA BROKE AT THE DISTAL OR PROXIMAL END. THE BATCH RECORD REVIEW SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. PROCESS DOCUMENTATION WAS REVIEWED AND INVESTIGATION VERIFIED THAT BEFORE THE PEEL FOIL IS SEALED, THE ANGLE OF THE CANNULA CARTRIDGE END (WOBBLE CIRCLE) WAS CHECKED 100% DURING THE ASSEMBLY PROCESS. NO SIMILAR NON-CONFORMANCE FOUND.

    Description of Event or Problem · 0

    DURING NEEDLE REPLACEMENT, THE NEEDLE CANNULA WAS FOUND TO BE BROKEN. NO OTHER INFORMATION WAS PROVIDED AS WELL AS WHETHER THE CANNULA BROKE AT THE DISTAL OR PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528090 CLICKFINE 32GX4MM DONGBAO 7ER PEN NEEDLE FMI CLICKFINE 32GX4MM DONGBAO 7ER 231190-02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown