BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS

    MDR report key: 6600811 · Received May 26, 2017

    Report

    Report Number
    MW5070075
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 19, 2017
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CLINICIAN PLACED A CORTRAK TUBE WITH THE ASSISTANCE OF THE CORTRAK ENTERAL ACCESS SYSTEM. AN X-RAY WAS TAKEN TO CONFIRM LOCATION OF THE TUBE. THE X-RAY IMPRESSION WAS THE TUBE EXTENDED INTO THE LEFT MAINSTEM, NO OBVIOUS PNEUMOTHORAX AT THIS TIME. A PNEUMOTHORAX DID DEVELOP AFTER REMOVAL AND A CHEST TUBE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377173 CORTRAK ENTERAL ACCESS CORTRAK ENTERAL ACCESS KNT CORPAK MEDSYSTEMS, INC. 3700

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention