BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY CATHETER DRAINAGE SYSTEM

    MDR report key: 6232604 · Received December 30, 2016

    Report

    Report Number
    MW5067112
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    August 7, 2016
    Report Date
    December 30, 2016
    Manufacturer
    BARD
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKAGE FROM FOLEY CATHETER DRAINAGE BAG EVEN WITH CLAMP CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866527 URINARY CATHETER DRAINAGE SYSTEM URINARY CATHETER DRAINAGE SYSTEM KNX BARD NGAR4206

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other