BEUDAMED
    FDA Adverse Event Summary report: N

    FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIEF SYSTEM

    MDR report key: 8357277 · Received February 21, 2019

    Report

    Report Number
    8357277
    Date Received
    February 21, 2019
    Date of Event
    February 10, 2019
    Report Date
    February 11, 2019
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CORPAK FARRELL BAG: BAG HUNG TO VENT GT DURING CGT FEEDS. DURING MED ADMINISTRATION CLAMP TO PATIENT INADVERTENTLY NOT UNCLAMPED ENTIRELY CAUSING OCCLUSION. INSTEAD OF ALARMING "OCCLUSION" ON THE FEEDING PUMP THE FEED BACKED UP INTO THE FARRELL BAG AND BEGAN TO LEAK AROUND THE BOTTOM OF THE BAG AROUND THE BLUE PIECE CONNECTING THE BAG TO THE TUBING. BAG REPLACED. REPORTEDLY THE NEXT BAG ALSO LEAKED AT ANOTHER PORT CLOSER TO THE PATIENT ON THE NEXT SHIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151372 FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIEF SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1