BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 15226370 · Received August 15, 2022

    Report

    Report Number
    3002806818-2022-00008
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 15, 2022
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE INJECTION WITH THE PEN NEEDLE (ARTICLE 700000176, BATCH 211168-01) WAS PAINFUL. THE NEEDLE WAS EXAMINED BY CUSTOMER AND NO ABNORMALITY WAS FOUND. NO MEDICAL INTERVENTION WAS REQUIRED. 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. NONE OF THE NEEDLES TESTED FROM THE SAME BATCH REACHED BEYOND THE MAXIMUM PENETRATION FORCE OF 1.0N (MAX 0.7 PER GB15811-2016).

    Description of Event or Problem · 0

    PATIENT FELT PAIN DURING INJECTION. NEEDLE WAS PLACED ON THE PEN INJECTOR NORMALLY WITHOUT ISSUES PRIOR TO INJECTION AND THERE WERE NO ABNORMALITY FOUND ON THE NEEDLE WHEN EXAMINED AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263402 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211168-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other