BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANO 2ND GENERATION

    MDR report key: 12348499 · Received August 19, 2021

    Report

    Report Number
    MW5103377
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER IS HAVING DIFFICULTY WITH HER INSULIN NEEDLE UPON REMOVAL. SHE SAID SHE IS NOT SURE IF THE INSULIN IS DELIVERED CORRECTLY OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237759 NANO 2ND GENERATION NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR