BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARRELL® -VALVE ENTERAL GASTRIC PRESSURE RELIEF SYSTEM

    MDR report key: 8178673 · Received December 19, 2018

    Report

    Report Number
    8178673
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 13, 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

    FEEDING TUBE WAS FOUND TO BE LEAKING OUT OF THE UPPER PART OF THE ORANGE PORT THAT GOES INTO THE FEEDING TUBE. UNMEASURABLE, LARGE AMOUNT OF TUBE FEEDING NOTED ON THE BEDDING. IT APPEARED AS IF THE FEEDING WAS STILL GOING INTO THE TUBE BUT IT WAS BACK-FLOWING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018552 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