BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1081382 · Received July 6, 2008

    Report

    Report Number
    1081382
    Event Type
    Malfunction
    Date Received
    July 6, 2008
    Date of Event
    May 22, 2008
    Report Date
    July 6, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CHEMOTHERAPY WAS INFUSING WHEN LEAK WAS NOTED BY A FAMILY MEMBER. THE RN CLAMPED THE PORT AND WAS ABLE TO CONTAIN THE CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TUBING, IV FPA B. BRAUN MEDICAL, INC. * J7N536

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR