BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER URINARY DRAINAGE BAG WITH ANTI-REFLUX VALVE

    MDR report key: 38215 · Received September 9, 1996

    Report

    Report Number
    38215
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 8, 1996
    Report Date
    August 9, 1996
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URINE DID NOT FLOW PAST THE ANTI-REFLUX VALVE INTO URINARY CATHETER BAG. THE PT COMPLAINED OF BLADDER DISCOMFORT. WHEN THE CATHETER BAG WAS REPLACED WITH A (DIFFERENT BRAND), URINE FLOWED SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER URINARY DRAINAGE BAG WITH ANTI-REFLUX VALVE URINARY DRAINAGE BAG KNX BAXTER HEALTHCARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR