BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUECARE BIOMEDIX TRANSFER TUBING

    MDR report key: 14236213 · Received April 27, 2022

    Report

    Report Number
    MW5109404
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 25, 2022
    Report Date
    April 25, 2022
    Manufacturer
    TRUECARE / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRUECARE BIOMEDIX PHARMACY TRANSFER TUBING, LARGE BORE UNIVERSAL SPIKE TUBING WAS USED WITH A REPEATER PUMP. HAD TWO UNRELATED INSTANCES WHERE THE TUBING IN THE ROUTER WAS CORED AND DRUG LEAKED. THE PLASTIC WAS RUBBED SO HARD THAT CREATED LEAKS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119392 TRUECARE BIOMEDIX TRANSFER TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA TRUECARE / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA TCBPTT001 20211218
    119393 TRUECARE BIOMEDIX TRANSFER TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA TRUECARE / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA TCBPTT001 20211218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention