BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 4253111 · Received October 7, 2014

    Report

    Report Number
    4253111
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    August 22, 2014
    Report Date
    October 7, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOBOFF FEEDING TUBE WAS BEING INSERTED BY RN USING CORTRAK ELECTRONIC GUIDANCE.FEEDING TUBE APPEARED TO BE IN STOMACH ACCORDING TO SCREEN. KUB X-RAY READING SHOWED PLACEMENT WAS IN THE LEFT LUNG. THE PHYSICIAN WAS NOTIFIED BY RADIOLOGIST. DOBOFF WAS REMOVED (B)(6).AT 0920 AND PATIENT DEVELOPED A PNEUMOTHORAX WHICH REQUIRED EMERGENT CHEST TUBE INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626687 CORTRAK 2 ENTERAL ACCESS SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R