BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPORT

    MDR report key: 1010516 · Received February 11, 2008

    Report

    Report Number
    1010516
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 7, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MEDPORT THAT WAS PLACED IN THE RIGHT SUBCLAVIAN BECAME OCCLUDED. THIS BECAME APPARENT UPON FLUSHING WITH SALINE. THE PATIENT STATED THEY FELT A "POP" AND PAIN. THE SITE BECAME SWOLLEN AND TENDER. FLUOROSCOPY REVEALED THAT THE CONTRAST EXTRAVASATED FROM THE PORT SITE ITSELF. VERY MINIMAL CONTRAST OPACIFIES THE ACTUAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPORT PORT, IMPLANTABLE LJT BARD ACCESS SYSTEMS * REQI0380

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR