BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL

    MDR report key: 23194132 · Received October 1, 2025

    Report

    Report Number
    MW5176825
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE NURSE WAS DRAWING BLOOD FROM IV LINE, USING VACUTAINER "SAF-T HOLDER BLOOD CULTURE DEVICE" FROM SMITHS MEDICAL (REF 96004), THE LURLOCK BROKE AWAY FROM THE NEEDLE CAUSING A SAFETY RISK FOR THE NURSE (SHARPS EXPOSURE). THIS HAS BEEN HAPPENING MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317883 SMITHS MEDICAL TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA ICU MEDICAL, INC. 96004 JU250305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other