BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL BLOOD GAS KIT PORTEX LINEDRAW

    MDR report key: 20891718 · Received December 10, 2024

    Report

    Report Number
    20891718
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    December 2, 2024
    Report Date
    December 2, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NOTE LEFT FOR CNS (CLINICAL NURSING SPECIALIST) FROM ONE OF THE CVICU (CARDIOVASCULAR INTENSIVE CARE UNIT) CHARGE RNS (REGISTERED NURSE) WITH TWO GREY BINS FULL OF ARTERIAL BLOOD GAS SYRINGES USED TO DRAW OFF ARTERIAL LINES THAT "EVERY SYRINGE WITH THIS LOT # THAT WE HAVE USED, WHEN WE EJECT THE BLOOD INTO THE CAP, THE BLOOD GOES ALL THE WAY THROUGH THE CAP AND LEAKS OUT". LOT NUMBER IS 6055473 AND NAME OF SYRINGE ON THE PRODUCT LABEL STATES "LINE DRAW ARTERIAL BLOOD SAMPLE SYRINGE WITH DRY LITHIUM HEPARIN FOR GASES AND ELECTROLYTES" BY SMITHS MEDICAL ASD, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534102 ARTERIAL BLOOD GAS KIT PORTEX LINEDRAW TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA SMITHS MEDICAL ASD, INC 4042-2 6055473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown