BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD

    MDR report key: 554395 · Received August 26, 2004

    Report

    Report Number
    MW1033092
    Event Type
    Malfunction
    Date Received
    August 26, 2004
    Date of Event
    August 16, 2004
    Report Date
    August 25, 2004
    Manufacturer
    BARD ACESS SYSTEMS
    Product Code
    DQD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 7/26/2004 PT HAD GROSHONG/MRI PORT INSERTION FOR BREAST CANCER-CHEST X-RAY SHOWED TIP IN RIGHT ATRIUM. PT RETURNED TO SURGERY AFTER ONE MONTH BECAUSE OF PORT MALFUNCTION. CATHETER WAS REMOVED, AND IT WAS NOTED THAT THERE WAS A FRACTURE OF CATHETER AT THE LEVEL WHERE THE CATHETER PASSED OVER THE CLAVICLE WITH MIGRATION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD GROSHONG CATHETER 8 FR. DQD BARD ACESS SYSTEMS * 22E04518

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other