BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH MEDICAL JELCO

    MDR report key: 19041332 · Received April 3, 2024

    Report

    Report Number
    MW5153525
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 1, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ATTEMPTED IV (INTRA VENOUS) STICK AN APPROXIMATELY 1 MM SEGMENT OF THE IV CATHETER SHEARED OFF, NOTED UPON REMOVAL OF IV CATHETER. ONLY NOTICED "MINISCULE PIECE" MISSING FROM CATHETER AFTER ATTEMPTED IV INSERTION. NO DIFFICULTIES WITHDRAWING AND DOES NOT THINK CATHETER WAS INTRAVASCULAR WHEN THIS OCCURRED. SMITH MEDICAL JELCO, 16G IV CATHETER, LOT: 4211138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334764 SMITH MEDICAL JELCO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC 4211138

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other