BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 512070 · Received February 18, 2004

    Report

    Report Number
    512070
    Event Type
    Other
    Date Received
    February 18, 2004
    Date of Event
    November 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    C. R. BARD, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CATHETER HAD BEEN ATTACHED TO A PORT AS ONE DEVICE. THE CATHETER BROKE OFF THE IMPLANTED PORT AND WAS RETRIEVED BEFORE ANY INJURY TO THE PT. THE TIP SNAPPED OFF THE CATHETER. THIS IS THE SECOND CASE OF THIS BREAKAGE, THAT HAS BEEN REPORTED, AND ANOTHER ONE HAPPENED MONTHS AGO THAT MAY BE RELATED TO THE PLACEMENT IN SUBCLAVIAN SITE FOR THIS CENTRAL CATHETER. SURGEON HAD IMPLANTED THE CENTRAL CATHETER FOR CHEMOTHERAPY. THE PORT HAD BEEN IMPLANTED AT ANOTHER FACILITY IN 2001 AND THAT FACILITY PROVIDED TRACKING INFO. THIS WAS AN OUTPT CASE HERE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/12/04: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, THEREFORE MFR CAN NOT DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ACCESS SYSTEMS PORT LJT C. R. BARD, INC. NOT KNOWN 0604550

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other