BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOTWIST MIS 32GX5MM

    MDR report key: 8142462 · Received December 6, 2018

    Report

    Report Number
    MW5081952
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 26, 2018
    Report Date
    November 26, 2018
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00169185389
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER ADVISED WRONG PEN NDLS SHIPPED: PEN NDL 32G 3/16 IN (5MM) NOVOTWIST PROVIDED WITH NUTROPIN 5 MG NUSPIN ORDER. NEEDLE DOESN'T FIT AND NURSE COORDINATOR TOLD MOTHER DURING TRAINING THAT NOVOTWIST NOT COMPATIBLE WITH DEVICE. CREATED NEW ORDER FOR COMPATIBLE PEN NDLS PER MOTHER REQUEST AND AGENT GETTING TO RESOLUTIONS TO SHIP. NEW START TO MED BUT DELAYED FURTHER DUE TO ISSUE BY 2 DAYS. CONTACTED MDO ABOUT DELAY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979328 NOVOTWIST MIS 32GX5MM NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 00169185389

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO