BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERAL ACE CONNECTOR

    MDR report key: 4283258 · Received November 13, 2014

    Report

    Report Number
    4283258
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    September 26, 2014
    Report Date
    November 13, 2014
    Manufacturer
    DALE MEDICAL PRODUCTS INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE ENTERED PATIENT'S ROOM AND FOUND TUBE FEEDINGS HAD LEAKED ON PATIENT AND BEDDING. ALL CONNECTIONS WERE APPROPRIATELY DONE, LEAKING WAS NOTED TO BE FROM THE VALVE. THIS WAS REPLACED, AND THE LEAKING STOPPED. THE PATIENT'S BLOOD GLUCOSE WAS MONITORED, AND NO HARM CAME TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733018 ENTERAL ACE CONNECTOR TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT DALE MEDICAL PRODUCTS INC * T14M68900 14585

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR