BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY DRAIN BAG

    MDR report key: 1883882 · Received October 17, 2010

    Report

    Report Number
    1883882
    Event Type
    Malfunction
    Date Received
    October 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    GAMBRO / HOSPAL
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CRRT BAG WAS LEAKING FROM THE WHITE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORY DRAIN BAG ACCESSORY DRAIN BAG KDI GAMBRO / HOSPAL NA 1023, BAG LOT0003193

    Patients

    Seq Age Sex Outcome Treatment
    1 * DIALYSIS