BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANO PEN NEEDLES 2ND GEN 4MM 32G

    MDR report key: 23136167 · Received September 24, 2025

    Report

    Report Number
    MW5176490
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    EMBECTA MEDICAL II LLC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE NANO 2ND GEN 4MM 32G PEN NEEDLES. I HAVE FOUND THAT I HAVE ABOUT A 5% FAILURE RATE FOR THESE NEEDLES. I HAVE REPORTED IT TO MY PHARMACY. I AM A PHARMACIST (RETIRED), SO I KNOW HOW TO PROPERLY INJECT. ON OCCASION, I WILL INJECT THE NEEDLE, BUT THE INSULIN WILL NOT FLOW OUT. IT'S AS IF THE NEEDLE IS BLOCK. SO, I HAVE TO REMOVE THE PEN NEEDLE, AND TRY A 2ND NEEDLE BEFORE I GET THE INSULIN INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494370 NANO PEN NEEDLES 2ND GEN 4MM 32G NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC. 320574 4347053

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male