BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2378370 · Received December 7, 2011

    Report

    Report Number
    2378370
    Event Type
    Malfunction
    Date Received
    December 7, 2011
    Date of Event
    November 24, 2011
    Report Date
    December 1, 2011
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SENT TO IR (INTERVENTIONAL RADIOLOGY) DUE TO PORT NOT FUNCTIONING PROPERLY. THE PLASTIC PORT WAS IDENTIFIED AS DEFECTIVE AND WAS REMOVED BY THE PHYSICIAN IN IR. A NEW METAL PORT WAS INSERTED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, PORT, IMPLANTED LJT BARD ACCESS SYSTEMS, INC. * REUL0213

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR CHEMOTHERAPY