BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS SAFETY NEEDLE

    MDR report key: 20902050 · Received December 11, 2024

    Report

    Report Number
    20902050
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    October 29, 2024
    Report Date
    November 5, 2024
    Manufacturer
    DUOPROSS MEDITECH CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CERTIFIED MEDICAL ASSISTANT (CMA) WAS TO ADMINISTER A VACCINE TO THE PATIENT. THE CMA WAS ENGAGING THE SAFETY. CMA THOUGHT THE SAFETY WAS ENGAGED FULLY. THE NEEDLE BENT AND POPPED BACK OUT AND STUCK THE CMA IN THE LEFT THUMB. CMA REPORTS THAT THE NEEDLES (25 X1") DO NOT HAVE A GOOD SAFETY ON THEM. THIS EVENT RESULTED IN THE CMA RECEIVING A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573584 DPS SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI DUOPROSS MEDITECH CORPORATION 100800000066

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female