BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT

    MDR report key: 2222800 · Received August 17, 2011

    Report

    Report Number
    2222800
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 17, 2011
    Manufacturer
    CARE FUSION
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH BILATERAL MALIGNANT PLEURAL EFFUSIONS. THE NURSE ATTEMPTED TO CONNECT THE 1000ML DRAINAGE KIT TO THE CATHETER AND IT FAILED TO SUCTION. A SECOND ATTEMPT TIME WITH PRODUCT FROM THE SAME LOT AND ALSO FAILED TO SUCTION. THE NURSE THEN CONNECTED A 500ML DRAINAGE KIT THAT DID FUNCTION CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEURX DRAINAGE KIT PLEURX DRAINAGE KIT DWM CARE FUSION * 0000318254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR