BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PORT

    MDR report key: 2213805 · Received April 15, 2008

    Report

    Report Number
    MW5021733
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BARD
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREAK NOTED IN PORT A CATH THAT REQUIRED SURGICAL REMOVAL. BREAK NOTED BELOW FIRST RIM FROM PRIOR DYE STUDY. LINEAR BREAK SEEN BUT REMOVED IN ONE PIECE. PURULENT DRAINAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PORT IMPLANTED PORT LJT BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other