BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE INSULIN SAFETY SYRINGE

    MDR report key: 22627395 · Received July 28, 2025

    Report

    Report Number
    MW5173383
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ULTI MED, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WENT TO USE A ULTICARE INSULIN SAFETY SYRINGE AND FRESHLY OPENED OUT OF THE PACKAGE IT WAS DIRTY. THERE'S SOMETHING STUCK TO THE NEEDLE. THIS IS A MAJOR HEALTH VIOLATION, THE SYRINGE IS SUPPOSED TO BE STERILIZED. IF I HADN'T NOTICED IT WAS DIRTY I WOULD HAVE INJECTED MYSELF WITH AN UNSTERILE NEEDLE WHICH COULD LEAD TO SERIOUS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751292 ULTICARE INSULIN SAFETY SYRINGE SYRINGE, PISTON FMF ULTI MED, INC. 240322

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female ALLEGRA.| LEUCOVORIN CALCIUM TABLETS.| METHOTREXATE.| MINOXIDIL.| NORGESTIMATE/ETHINYL ESTRADIOL 0.25-0.035 MG.