BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIGEAR URINARY DRAIN BAG

    MDR report key: 6653104 · Received June 15, 2017

    Report

    Report Number
    MW5070513
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Date of Event
    May 25, 2017
    Report Date
    May 6, 2017
    Manufacturer
    STERIGEAR, LLC
    Product Code
    FCN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COLLECTION CHAMBER LOCKED AND NOT DRAINING INTO INDWELLING CATHETER BAG (NEGATIVE PRESSURE VALVE STUCK AND NON - RETURN VALVE CLOSED.) REMOVED WHEN PT ADMIT TO ICU. DATES OF USE: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426583 STERIGEAR URINARY DRAIN BAG FIG LEAF DRAIN BAG FCN STERIGEAR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR