BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORFLO NG TUBE

    MDR report key: 1871337 · Received October 13, 2010

    Report

    Report Number
    1419949-2010-00011
    Event Type
    Death
    Date Received
    October 13, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 8, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FEEDING TUBE PLACEMENT IS DEPENDENT ON THE USER NOT THE FEEDING TUBE. NEITHER THE FEEDING TUBE NOR THE CORTRAK WERE RETURNED TO CORPAK FOR EVALUATION. HOWEVER, THE ELECTRONIC PLACEMENT FILE FROM THE CORTRAK WAS FORWARDED FOR OUR REVIEW. THE PLACEMENT WAS REVIEWED AND SHOWED THE FEEDING TUBE IN THE RIGHT LUNG.

    Description of Event or Problem · 1

    USING THE CORTRAK SYSTEM, A NG TUBE WAS INCORRECTLY PLACED INTO THE PT'S RIGHT LUNG BY A NURSE AT ABOUT 10:20PM ON (B)(6) 2010. FEED WAS THEN GIVEN FOR ABOUT 1 HOUR. THE PT HAD AN X-RAY AT 5:30AM ON (B)(6) 2010 WHICH SHOWED THAT THE TUBE HAD BEEN INCORRECTLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO NG TUBE NG TUBE KNT CORPAK MEDSYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death