BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I.V. ADMINISTRATION SET 92" LENGTH WITH 15U FILTER IN DRIP CHAMBER

    MDR report key: 21549522 · Received March 7, 2025

    Report

    Report Number
    MW5167400
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    March 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    TRUECARE BIOMEDIX / US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I AM A NURSE WHO WAS PREPARING AN IV HYDRATION INFUSION FOR A PATIENT. WHEN PREPARING OR PREPPING THE IV BAG WITH THE TRUECARE BIOMEDIX I.V. ADMINISTRATION SET, THE DISTAL Y-SITE/INJECTION PORT SITE WAS PULLING IN AIR FROM THAT SITE AND ALSO LEAKING FLUIDS OUT OF THE END OF THE TUBING EVEN WITH THE IV TUBING BEING CLAMPED. THE Y-SITE/INJECTION PORT SITE HAS A MANUFACTURER DEFECT IN WHICH THE AIR WOULD BE INTRODUCED INTO THE PATIENT'S VEIN AND INTO THE PATIENT'S BODY WHICH COULD HAVE CAUSED AN AIR EMBOLISM IF NOT ADDRESSED. AIR EMBOLISM CAN CAUSE LIFE THREATENING AND DANGEROUS ADVERSE EVENT FOR THE PATIENT. THIS TUBE COULD HAVE CAUSED HARM TO THE PATIENT BUT WAS STOPPED BEFORE ADMINISTERING IT WHEN THE DEFECT WAS NOTED. THIS HAS HAPPENED ON A FEW OCCASIONS WITH USING THE TRUECARE BIOMEDIX-USA IV TUBING SET 92" LENGTH WITH 15U MICRON FILTER. THIS TUBING SHOULD BE RECALLED AND INSPECTED BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338636 I.V. ADMINISTRATION SET 92" LENGTH WITH 15U FILTER IN DRIP CHAMBER SET, ADMINISTRATION, INTRAVASCULAR FPA TRUECARE BIOMEDIX / US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA 24026C101550B

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female