BEUDAMED
    FDA Adverse Event Other Summary report: N

    I.V. ADMINISTRATION SET

    MDR report key: 23224131 · Received October 6, 2025

    Report

    Report Number
    MW5176969
    Event Type
    Other
    Date Received
    October 6, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 2, 2025
    Manufacturer
    US INFUSION LLC. D/B/A TRUECAR BIORMEDIX-USA
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WAS SCHEDULED TO RECEIVE AN IV INFUSION. A 1000 ML NORMAL SALINE (NS) IV BAG (MANUFACTURER: BRAUN, LOT #J5E813) WAS PREPARED. THE CLINICIAN SPIKED THE IV BAG CORRECTLY USING THE APPROPRIATE IV TUBING (MANUFACTURER: TRUECARE BIOMEDIX, LOT #10166303). DURING INSERTION OF THE TUBING SPIKE INTO THE IV PORT, THE TIP OF THE SPIKE BROKE OFF AND FELL INTO THE IV BAG, LEAVING THE BROKEN PIECE FLOATING IN THE SOLUTION. THE REMAINDER OF THE TUBING REMAINED SECURELY CONNECTED TO THE IV PORT, AND NO LEAKAGE OCCURRED. PATIENT IS A HEALTHY 21-YEAR-OLD MALE THAT WAS RECEIVING A VITAMIN INFUSION FOR ACTIVE COVID DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868612 I.V. ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA US INFUSION LLC. D/B/A TRUECAR BIORMEDIX-USA 10166303

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male