BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 EAS

    MDR report key: 3750350 · Received March 6, 2014

    Report

    Report Number
    3750350
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    February 22, 2014
    Report Date
    March 5, 2014
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STROKE PT, WHO WAS UNABLE TO FOLLOW A COMMAND TO SWALLOW, NEEDED A FEEDING TUBE PLACED. THE FIRST ATTEMPT BY THE NURSES TO PLACE A CORTRAK ENDED WHEN RESISTANCE WAS MET AT 50 CM. TUBE WAS WITHDRAWN. A SECOND ATTEMPT MET NO RESISTANCE AND WAS ADVANCED TO 60 CM AND SECURED. NO AUSCULTATION WAS NOTED WHEN 30 CC AIR WAS PUSHED. ON THE SCREEN, THE TUBE DID NOT APPEAR TO BE IN THE ABDOMEN. THE TUBE WAS WITHDRAWN AND MINUTES LATER, THE PT STARTED TO WHEEZE. CXR REVEALED AT RIGHT MODERATE PNEUMOTHORAX. A CHEST TUBE WAS INSERTED AND REMOVED TWO DAYS LATER. CORTRAK 2 EAS WAS USED WITH BOTH ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134229 CORTRAK 2 EAS FEEDING TUBE KNT CORPAK MEDSYSTEMS, INC. 20-9431 TRAK 2

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R