BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK

    MDR report key: 7689217 · Received July 13, 2018

    Report

    Report Number
    MW5078368
    Event Type
    Death
    Date Received
    July 13, 2018
    Date of Event
    May 26, 2018
    Report Date
    July 11, 2018
    Manufacturer
    HALYARD HEALTH INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING A #12F COTRAK 2 NASOGASTRIC / NASOINTESTINAL FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITTING STYLET AND IV CONNECTOR WITH CORTRAK 2 PLACEMENT DEVICE, THE TRACING READ AMBIGUOUSLY AFTER MULTIPLE ATTEMPTS AT PLACEMENT. IT WAS NOTED THAT DURING THE PROCEDURE THE PT, WHOM HAD DEMENTIA WAS TAKING AND MOVING REQUIRING THE PROCEDURE TO BE STOPPED AND RESTARTED SEVERAL TIMES. STAFF DID NOT TRUST READING AND OBTAINED AN ORDER FOR A CHEST X-RAY TO CONFIRM GASTRIC TUBE PLACEMENT. THE CHEST X-RAY INSTEAD REVEALED THE TUBE HAD ENTERED THE LEFT BRONCHUS AND PERFORATED THE LEFT APICAL LUNG. ONCE THE PERFORATION WAS IDENTIFIED, THE TUBE WAS PULLED AND THE PT BEGAN TO QUICKLY DECLINE REQUIRING RE-INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528296 CORTRAK TUBES GASTROINTESTINAL (AND ACCESSORIES) KNT HALYARD HEALTH INC. 0202903884

    Patients

    Seq Age Sex Outcome Treatment
    0 84 YR Death
    1 84 YR Death