BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON URINARY DRAIN BAG WITH FLUTTER VALVE

    MDR report key: 2577539 · Received May 10, 2012

    Report

    Report Number
    1451040-2012-00007
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    CONOD MEDICAL CO. LTD.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE DISCONTINUED PURCHASING THIS PRODUCT ON JULY 21, 2011 AND WE DISCONTINUED PROVIDING THE PRODUCT TO CYPRESS CUSTOMERS IN FEB 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT URINARY DRAINAGE BAG TUBING WAS NOT DRAINING PROPERLY AND THAT THE TUBING HAS TO BE "MILKED" EVERY COUPLE OF HOURS - WHETHER THERE IS MUCOUS/SEDIMENTATION OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON URINARY DRAIN BAG WITH FLUTTER VALVE URINARY DRAIN BAG KNX CONOD MEDICAL CO. LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK