BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 14961119 · Received July 8, 2022

    Report

    Report Number
    3005170966-2022-00004
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    May 27, 2022
    Report Date
    July 8, 2022
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE INJECTION WITH THE PEN NEEDLE (ARTICLE 700000176, BATCH 201259-02) IS PAINFUL. THE CUSTOMER DIDN'T RETURN ANY NEEDLES FOR INVESTIGATION. THE INVESTIGATION STARTED WITH A REVIEW FOR ANY INTERNAL DEVIATIONS DURING PRODUCTION, WHICH SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS. PENETRATION FORCE TESTING WAS PERFORMED WITH 5 SAMPLES RETAINED FROM THE SAME BATCH NUMBER. THE TESTING SET-UP INCLUDED SCREWING THE NEEDLE ONTO THE HOLDING FIXTURE AND REMOVING THE INNER AND OUTER PROTECTIVE CAP. THE METHOD INCLUDED PENETRATION IN FOIL UP TO NOMINAL LENGTHS WITH A DEFINED SPEED. NONE OF THE NEEDLES TESTED FROM THE SAME BATCH REACHED BEYOND THE MAXIMUM PENETRATION FORCE OF 1.0N.

    Description of Event or Problem · 0

    THE PATIENT CAME TO THE HOSPITAL TO GIVE FEEDBACK THAT SHE FELT THAT THE INJECTION WAS VERY PAINFUL COMPARED WITH HER PREVIOUS INJECTIONS AND DOUBTED THAT THE NEEDLE IS SHARP. THE DOCTORS HAVE RECOMMENDED TO THE PATIENT TO CONTINUE TO MONITOR THE ISSUE AND TO NOT RE-USE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849133 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 201259-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other