BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2

    MDR report key: 8564184 · Received April 30, 2019

    Report

    Report Number
    8564184
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    March 19, 2019
    Report Date
    April 2, 2019
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CORTRAK DUODENAL FEEDING TUBE WAS BEING RE-INSERTED FOLLOWING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IN TO A PATIENT WHO WAS ORALLY INTUBATED, VENTED, AND WHOM HAD A KNOWN, LARGE, HIATAL HERNIA. AFTER PLACEMENT, AN ABDOMINAL FILM WAS ORDERED TO VERIFY PLACEMENT; IT WAS NOTED TO BE "ELONGATED" ON THE X-RAY. A SECOND ABDOMINAL FILM WAS ORDERED WITH A LATERAL VIEW AND DYE INTRODUCED. RESULTS SUPPORTED GASTRIC PERFORATION; PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. DUODENAL FEEDING TUBE WAS FOUND TO HAVE PERFORATED THE STOMACH AT THE GREATER FUNDAL CURVATURE. PUNCTURE WAS SURGICALLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357743 CORTRAK 2 TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 0203155920

    Patients

    Seq Age Sex Outcome Treatment
    1 30660 DA Hospitalization| O| R