BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ATRAUM THORACIC CATHETER

    MDR report key: 12689148 · Received October 22, 2021

    Report

    Report Number
    MW5104904
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    October 19, 2021
    Report Date
    October 20, 2021
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    GBS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF OBTAINED A CHEST TUBE AND UPON OPENING DISCOVERED THAT THE TUBE APPEARED TO HAVE PLASTIC PARTICLES INSIDE THE TUBE. THE TUBE WAS NOT USED AND PLACED ASIDE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576379 AXIOM ATRAUM THORACIC CATHETER CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY GBS AXIOM MEDICAL, INC. 1902409

    Patients

    Seq Age Sex Outcome Treatment
    1