BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL FEEDING TUBE

    MDR report key: 2820618 · Received October 29, 2012

    Report

    Report Number
    3009124963-2012-00028
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FEEDING TUBE PLACEMENT IS DEPENDENT ON THE CLINICIAN AND PT. THE ACTUAL TUBE DOES NOT INFLUENCE WHERE IT IS PLACED. NO FEEDING TUBE SAMPLE IS AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: A FEEDING TUBE WAS PLACED USING THE CORTRAK ETERAL DEVICE. AN X-RAY WAS DONE WITHIN A HALF HOUR TO CONFIRM PLACEMENT AND IT WAS DISCOVERED THAT THE TUBE WAS IN THE RIGHT LUNG. A HYDROPNEUMOTHORAX RESULTED WAS SMALL AND SELF-RESOLVING. NO CHEST TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTRAK ENTERAL FEEDING TUBE FEEDING TUBE (NASOGASTRIC TUBE) KNT CORPAK MEDSYSTEMS 20-9551TRAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other