BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL IMPLANTABLE PORT

    MDR report key: 2892179 · Received December 20, 2012

    Report

    Report Number
    2892179
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    September 11, 2012
    Report Date
    December 20, 2012
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S PORT-A-CATH WAS BEING REMOVED IN THE OR; CATHETER HAD ALREADY BEEN DOCUMENTED AS BROKEN OFF THE PORT. UNABLE TO REMOVE CATHETER IN THE OR WENT TO INTERVENTIONAL RADIOLOGY (IR) FOR REMOVAL OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL IMPLANTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. 45-366 1347895

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NO OTHER THERAPIES