BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON URINARY DRAIN BAG WITH FLUTTER VALVE

    MDR report key: 2577537 · Received May 10, 2012

    Report

    Report Number
    1451040-2012-00009
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    CONOD MEDICAL CO. LTD.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE DISCONTINUED PURCHASING THIS PRODUCT ON (B)(4) 2011 AND WE DISCONTINUED PROVIDING THE PRODUCT TO CYPRESS CUSTOMERS IN (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE URINARY DRAINAGE BAG ANTI REFLUX VALVE DOES NOT WORK. WE EXAMINED THE RETURNED SAMPLE, AND, IN THE COURSE OF OUR EXAMINATION, WE WERE NOT ABLE TO DUPLICATE AND OBSERVE THE REPORTED ISSUE.

    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. CZJ10-01

    Patients

    Seq Age Sex Outcome Treatment
    1