BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOME TITANIUM SINGLE LUMEN PORT

    MDR report key: 2784066 · Received September 17, 2012

    Report

    Report Number
    2784066
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 17, 2012
    Manufacturer
    C. R. BARD, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    BARD ACCESS SYSTEMS TITANIUM DOME IMPLANTABLE PORT CATHETER TIP SEPARATED FROM CATHETER. PROBLEM NOTED ON PREOPERATIVE RADIOGRAPH. PORT AND REMAINING PORTION OF CATHETER REMOVED IN OR, PT REFERRED TO ANOTHER FACILITY WITH INVASIVE CARDIAC CAPABILITY TO RETRIEVE THE PART.MANUFACTURER RESPONSE FOR IMPLANTABLE INFUSION PORT, BARDPORT (PER SITE REPORTER).INFORMATION TAKEN, WILL RESPOND LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOME TITANIUM SINGLE LUMEN PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C. R. BARD, INC. 0602850 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *