BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE MEDICAL TECHNOLOGIES INC.

    MDR report key: 22480364 · Received July 11, 2025

    Report

    Report Number
    3001451226-2025-00004
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 26, 2025
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES
    Product Code
    JKA
    UDI-DI
    20612479206070
    PMA / PMN Number
    K123987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COULD NOT REPRODUCE PROBLEM DURING TESTING.

    Description of Event or Problem · 0

    DURING REMOVAL OF THE BUTTERFLY NEEDLE, THE YELLOW COMPONENT, THAT COVERS THE NEEDLE AFTER USE, DETACHED UNEXPECTEDLY, RESULTING IN THE NEEDLE NO LONGER BEING COVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895166 INNOVATIVE MEDICAL TECHNOLOGIES INC. PUSH BUTTON BLOOD COLLECTION SET JKA INNOVATIVE MEDICAL TECHNOLOGIES 241026M 20612479206070

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown