BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 15910010 · Received December 2, 2022

    Report

    Report Number
    3002806818-2022-00026
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 21, 2022
    Report Date
    December 2, 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 NURSE OBSERVED DIFFICULTY IN NEEDLE INSERTION DURING AN INSULIN INJECTION TO A PATIENT. THE PATIENT FELT THAT THE INJECTION WAS VERY PAINFUL. UPON INSPECTION, THE NURSE FOUND THAT THE NEEDLE WAS BENT. THE BENT NEEDLES WAS REPLACED WITH A NEW ONE WITH NO ISSUES. A REVIEW OF PRODUCTION RECORDS SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 211269. PENETRATION TESTING WAS COMPLETED ON 5 RETAINED SAMPLES FROM THE SAME LOT. NO ABNORMALITIES WERE FOUND AND THE RESULTS SHOW A MAXIUM PENETRATION FORCE OF 0.79N, MEETING THE MAXIMUM 1N SPECIFICATION.

    Description of Event or Problem · 0

    THE NURSE OBSERVED DIFFICULTY IN NEEDLE INSERTION DURING AN INSULIN INJECTION TO A PATIENT. THE PATIENT FELT THAT THE INJECTION WAS VERY PAINFUL. UPON INSPECTION, THE NURSE FOUND THAT THE NEEDLE WAS BENT. THE BENT NEEDLES WAS REPLACED WITH A NEW ONE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947162 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211269-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown