BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRACK

    MDR report key: 21730009 · Received March 31, 2025

    Report

    Report Number
    MW5168383
    Event Type
    Death
    Date Received
    March 31, 2025
    Date of Event
    December 10, 2024
    Report Date
    March 26, 2025
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT ADMITTED FOR A FALL AT HOME RESULTING IN A FRACTURE OF THE DISTAL CLAVICLE W MINIMAL DISPLACEMENT. NGT (NASOGASTRIC TUBE)/ CORTRACK WAS ORDERED THAT RESULTED IN 3-MINUTE CARDIAC ARREST. INJURY TO THE RIGHT MAINSTEM AND THROUGH THE LUNG. ABDOMINAL X-RAY SHOWED FEEDING TUBE WAS LOOPED OVER RIGHT HEMITHORAX CONCERNING FOR TRAUMATIC BRONCHOPLEURAL FISTULA AND POSSIBLE EXTENDING INTO THE PLEURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912271 CORTRACK TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death