BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOFLO ANTIREFLUX W/SPLGD NDLESS SAMPLING

    MDR report key: 6198314 · Received December 22, 2016

    Report

    Report Number
    9612030-2016-00842
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    EXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/22/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A URINE DRAIN BAG. THE CUSTOMER STATES THAT THE CONNECTION WITH THE BALLOON FROM THE PHYCON CATHETER AND THE DRAIN BAG WAS LOOSE AND BECAME DETACHED FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849369 MONOFLO ANTIREFLUX W/SPLGD NDLESS SAMPLING URINE DRAIN BAG EXG COVIDIEN 6308

    Patients

    Seq Age Sex Outcome Treatment
    1