BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELMONT MEDICAL 3-SPIKE DISPOSABLE SET

    MDR report key: 17754519 · Received September 15, 2023

    Report

    Report Number
    17754519
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 12, 2023
    Report Date
    September 13, 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 MASSIVE TRANSFUSION, THE BELMONT TUBING REPORTEDLY ¿FELL APART" STAFF REPORTED. ¿THE SPIKE OF THE TUBING CAME OFF OF THE TUBING" AND ¿THE TUBING WAS NOT ABLE TO BE PUT BACK TOGETHER.¿ A NEW TUBING SET-UP HAD TO BE PERFORMED DURING EMERGENT RESUSCITATION AND TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040691 BELMONT MEDICAL 3-SPIKE DISPOSABLE SET WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT, LLC 903-00006P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown