BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRI LOW-PROFILE IMPLANTED PORT

    MDR report key: 2070734 · Received April 19, 2011

    Report

    Report Number
    2070734
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 20, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BARD ACCESS SYSTEMS INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTS TO FACILITY WITH NON-FUNCTIONING PORT. THE PORT WAS ACCESSED AND WOULD NOT FLUSH OR ASPIRATE. THE PORT WAS BELIEVED TO BE OCCLUDED. THE PATIENT WAS BROUGHT TO THE OR FOR A REVISION. THE PORT WAS ACCESSED AND CONTRAST WAS INJECTED. EXTRAVASATION CONTRAST WAS NOTED AT THE PORT HUB CONNECTION. THE PORT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI LOW-PROFILE IMPLANTED PORT PORT, CATHETER,IMPLANTED LJT BARD ACCESS SYSTEMS INC UNK REUD1022

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR