BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINGE KIT

    MDR report key: 4121096 · Received September 18, 2014

    Report

    Report Number
    4121096
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    RN WAS USING THE DRAINING PLEUREX DRAIN. WHEN THE RN ATTEMPTED TO PUSH BULB DRAIN INTO THE CATHETER CONNECTION, THE END BROKE OFF IN THE CATHETER CONNECTION. PULLED BROKEN TIP OUT OF THE CATHETER WITH HEMOSTATS AND WAS THEN ABLE TO OBTAIN ANOTHER BULB AND DRAIN CATHETER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579725 PLEURX DRAINGE KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION * 0000640517

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES