BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC CV CATHETER 2.7F SINGLE-LUMEN CV CATHETER WITH SUR

    MDR report key: 3802374 · Received February 21, 2014

    Report

    Report Number
    3006260740-2014-00066
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 29, 2014
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT RETURNED FROM O.R. WITH LEFT CHEST WALL BROVIAC PLACED. AT 2130 PT NECK, JAW AND LEFT CHEST NOTED TO BE SWOLLEN AND RED. IV FLUID STOPPED IMMEDIATELY AND DOCTOR NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110321 BROVIAC CV CATHETER 2.7F SINGLE-LUMEN CV CATHETER WITH SUR LJS C.R. BARD, INC (BASD) REVA0483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention