BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 6.6 FR S/L CENTRAL VENOUS CATHETER

    MDR report key: 1071767 · Received July 7, 2008

    Report

    Report Number
    3006260740-2008-00034
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS IMPLANTED. THE CHEMOTHERAPY BEGAN THE DRUGS WERE GIVEN, PAIN & EXTRAVASATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 6.6 FR S/L CENTRAL VENOUS CATHETER LJS C. R. BARD INC. (BASD) HURG0545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention