BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR AND SYRINGE, ANGIOGRAPHIC

    MDR report key: 18257876 · Received December 1, 2023

    Report

    Report Number
    MW5148716
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    September 7, 2022
    Report Date
    November 30, 2023
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY LLC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVICE MALFUNCTION DESCRIPTION: AFTER THE MACHINE HAD BEEN RUNNING NORMALLY FOR A PERIOD OF TIME, IT ALWAYS REPORTED "PIPELINE STUCK" AND COULD NOT CONTINUE. PRELIMINARY ACTION: THE SENSOR FAILED DUE TO THE ADHESION OF THE CHEMICAL LIQUID IN THE PIPELINE. AFTER CLEANING, THE SENSOR WAS USED NORMALLY AND THE MACHINE WAS NORMAL. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048523 INJECTOR AND SYRINGE, ANGIOGRAPHIC INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT LIEBEL-FLARSHEIM COMPANY LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown