BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 6990450 · Received October 31, 2017

    Report

    Report Number
    6990450
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    July 25, 2017
    Report Date
    October 5, 2017
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIFFICULT TO ADVANCE THE CATHETER WITH THE POTENTIAL FOR A PNEUMOTHORAX. WHILE ADVANCING THE CATHETER PATIENTS DESCRIBE MORE PAIN THAN EXPECTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769807 CARDINAL HEALTH APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH 200, LLC 30-CE18SF

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR