BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GVS EASYDROP FLOW REGULATOR

    MDR report key: 16399405 · Received February 16, 2023

    Report

    Report Number
    MW5115032
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 14, 2023
    Manufacturer
    TRUECARE BIOMEDIX / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENTS 1 HOUR INFUSION INFUSED OVER 35-40 MINUTES. THE INFUSION VOLUME IS 100 ML, AND THE RATE-CONTROLLED TUBING WAS SET TO 100 ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385721 GVS EASYDROP FLOW REGULATOR SET, ADMINISTRATION, INTRAVASCULAR FPA TRUECARE BIOMEDIX / US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA TCBINF033G 21087C1211

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female