BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHLITE PEN NEEDLES

    MDR report key: 15348248 · Received September 1, 2022

    Report

    Report Number
    MW5111845
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 27, 2022
    Report Date
    August 30, 2022
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    FMI
    UDI-DI
    08317235131
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TECHLITE PEN NEEDLES ARE BENT, PRIOR TO BEING USED. OPEN THE PEN NEEDLE AND THE NEEDLE THAT IS INSERTED INTO THE INSULIN PEN IS BENT, AND CANNOT BE USED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301348 TECHLITE PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ARKRAY FACTORY USA, INC. B462K3 08317235131

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female