BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-SPIKE DISPOSABLE SET

    MDR report key: 18343952 · Received December 18, 2023

    Report

    Report Number
    18343952
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    August 7, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BELMONT INSTRUMENT, LLC
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A MASSIVE TRANSFUSION EVENT USING BELMONT TUBING, ONE OF THE SPIKES FROM THE Y-SITE BROKE OFF INTO THE BAG OF BLOOD WHEN THE BAG WAS SPIKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920670 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT, LLC 903-00006P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown