BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4 MM 5/32 NANO

    MDR report key: 23923584 · Received December 30, 2025

    Report

    Report Number
    MW5181466
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Report Date
    December 23, 2025
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT'S MOTHER STATES WHEN ADMINISTERING NORDITROPIN FLEXPRO PEN USING 32G 4MM NEEDLES SOMETIMES THE NEEDLE DOES NOT PUNCTURE THE SKIN AND SHE HAS TO GET A NEW ONE. FEELS LIKE NEEDLES MAY BE DEFECTIVE OVER LAST TWO SHIPMENTS BECAUSE WHEN SHE GETS A DIFFERENT NEEDLE THEN IT WORKS. SAYS HER SON KNOWS WHEN ITS GOING TO HURT. WHEN IT DOESN'T PUNCTURE THE SKIN IT CREATES A BUBBLE UNDER THE SKIN AS IF NOT GETTING DEEP ENOUGH. ADVISED WE COULD TRY A DIFFERENT NEEDLE SIZE TO SEE IF WORKS BETTER, ALTHOUGH NANOS ARE THE SMALLEST NEEDLE SIZE AVAILABLE. SHE STATED SHE DID NOT WANT TO TRY ANOTHER NEEDLE SIZE AT THIS TIME. HAS ORDER DOWNLOADED FOR MORE PEN NEEDLES. WILL TRY THESE TO SEE IF ANY BETTER AND GET BACK TO US IF ISSUE CONTINUES. NO MISSED DOSE OR ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878428 PEN NEEDLE 32G 4 MM 5/32 NANO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male NORDITROPIN FLEXPRO PEN..