BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG, ACCESSORY DRAIN

    MDR report key: 1872747 · Received September 26, 2010

    Report

    Report Number
    1872747
    Event Type
    Malfunction
    Date Received
    September 26, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 26, 2010
    Manufacturer
    GAMBRO
    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

    UF DRAIN BAG THAT WAS LEAKING WHILE IN USE DURING CRRT ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG, ACCESSORY DRAIN ACCESSORY DRAIN BAG KDI GAMBRO NA 0002171;

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DIALYSIS