BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Cook

    MDR report key: 8699569 · Received June 14, 2019

    Report

    Report Number
    8699569
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 21, 2019
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CT GUIDED DRAIN PLACEMENT TO LEFT LOWER QUADRANT OF ABDOMEN, THE COOK BRAND GUIDE WIRE BECAME STUCK IN PATIENT AFTER PLACING THE DRAIN. MD HAD TO REMOVE THE DRAIN, RETRIEVE THE GUIDE WIRE, THEN START OVER WITH THE DRAIN PLACEMENT. WHEN THE DRAIN WAS REMOVED IT WAS NOTED THAT THE END WAS SPLIT. CT SCAN WAS DONE TO ASSURE THAT NOTHING WAS LEFT IN THE PATIENT. ANOTHER DRAIN WAS PLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493097 Cook WIRE, GUIDE, CATHETER DQX COOK MEDICAL LLC G00529 9632252

    Patients

    Seq Age Sex Outcome Treatment
    1 9855 DA