BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FLO-R 23G PUSH BUTTON

    MDR report key: 20611298 · Received November 4, 2024

    Report

    Report Number
    MW5162163
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 30, 2024
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LAB STAFF MEMBER PUSHED SAFETY BUTTON TO RETRACT THE NEEDLE. NEEDLE ONLY RETRACTED HALFWAY LEAVING THE NEEDLE STILL EXPOSED. STAFF DISPOSED OF THE NEEDLE RIGHT AWAY INTO THE SHARPS CONTAINER TO AVOID GETTING STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132303 ULTRA FLO-R 23G PUSH BUTTON TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA INNOVATIVE MEDICAL TECHNOLOGIES, INC. 240127M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown