BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 18310017 · Received December 12, 2023

    Report

    Report Number
    18310017
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    October 10, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE BELMONT FOR RAPID TRANSFUSION, THE TUBING WAS INSERTED AND WAS LEAKING. THIS DEVICE WAS REMOVED AND REPLACED WITH ANOTHER SET, AND THEN WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694659 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT LLC 903-00006

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Female