BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTING STYLET ENFIT CONNEC

    MDR report key: 22193694 · Received June 12, 2025

    Report

    Report Number
    22193694
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 6, 2025
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SMALL BORE FEEDING TUBE PLACED BY NURSING [REDACTED DATE], ABD XR [ABDOMINAL XRAY] READ AS TUBE TIP IN DISTAL STOMACH. CTABD [CT OF ABDOMEN] ON [DATE REDACTED], THREE DAYS LATER, CONFIRMED TUBE IN PERIPYLORIC REGION. MORNING OF [DATE REDACTED] PATIENT COMPLAINING OF ABDOMINAL PAIN AND NAUSEA. ABD XR [ABDOMINAL XRAY] SHOWED TUBE WITH BROKEN DISTAL FRAGMENT OF 26 CM IN THE STOMACH. TUBE REMOVED FROM NARES ON [DATE REDACTED] AND BROKEN FRAGMENT REMAINED ATTACHED AT TIME OF REMOVAL. THIS DEVICE DID NOT HAVE ANY REPORTED CLOGS OR REQUIRE ANY EXCESS PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670443 CORTRAK 2 NG/NI FEEDING TUBE W/ ELECTROMAGNETIC TRANSMITTING STYLET ENFIT CONNEC TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female