BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARRELL® -VALVE ENTERAL GASTRIC PRESSURE RELIEF SYSTEM

    MDR report key: 8284849 · Received January 29, 2019

    Report

    Report Number
    8284849
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    November 5, 2018
    Report Date
    December 24, 2018
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FARRELL BAG TUBE WAS CONNECTED TO MICKEY FEEDING TUBE AND WAS LEAKING AROUND THE CONNECTION PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79948 FARRELL® -VALVE ENTERAL GASTRIC PRESSURE RELIEF SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 20-4100 SB182294

    Patients

    Seq Age Sex Outcome Treatment
    1