BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANO PEN NEEDLES 2ND GENERATION

    MDR report key: 24134419 · Received January 21, 2026

    Report

    Report Number
    MW5182591
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 15, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE VICTOZA FOR MY DIABETES, WHICH I'VE BEEN TAKING ON AND OFF FOR 13 YEARS, WITHOUT ANY PROBLEMS. RECENTLY, I GOT ADDITIONAL PEN NEEDLES - THEY ARE FROM EMBECTA AND INDICATE 2ND GENERATION. WHEN I TRY TO USE THEM, THE NEEDLES GO INTO MY STOMACH BUT WON'T DISPENSE ANY MEDICATION. IF I REMOVE THE NEEDLES, THE MEDICATION THEN SQUIRTS OUT. OCCASIONALLY, I NOTICE THE PEN NEEDLE TIPS ARE BENT. I TRIED CONTACTING NOVO, EMBECTA, AND MY DOCTOR. MY DOCTOR SAYS TO TAKE THEM BACK. NOVO SAYS IT IS NOT THEIR PROBLEM. EMBECTA ASKED FOR THINGS LIKE BATCH NUMBER, MANUFACTURING DATE, ETC., THEN STOPPED RESPONDING. I'VE SINCE HAD TO CHANGE THE LOCATION WHERE I INJECT TO MY LEGS, WHICH ARE A LOT LESS CONVENIENT. I DON'T KNOW WHY THEIR "FIRST GENERATION" OF THE NEEDLES HAVE WORKED FOR YEARS, AND THE SECOND GENERATION DOES NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188894 NANO PEN NEEDLES 2ND GENERATION NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC. 320560 5140118

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Disability ALLOPURINOL.| ATORVASTATIN.| BUPROPION.| LISINORPIL.| METFORMIN.| METROPOLOL.| NITROGLYCERINE.| VITAMINS.