BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER PORT

    MDR report key: 3111947 · Received March 18, 2013

    Report

    Report Number
    3111947
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    September 12, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED POWER PORT INSERTION, THE GUIDEWIRE BECAME COILED AT THE NEEDLE INSERTION SITE WITHIN THE VESSEL. THE NEEDLE WAS SLIGHTLY WITHDRAWN. THE GUIDEWIRE WAS ADVANCED APPROXIMATELY 1 CM WITH EASE AND UPON ATTEMPTING TO REMOVE THE WIRE, IT SNAPPED, LEAVING A SHORT PORTION WITHIN THE PATIENT. THE REMAINING PIECE OF THE GUIDEWIRE WAS SUCCESSFULLY REMOVED BY INTERVENTIONAL RADIOLOGY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112853 POWER PORT MEDIPORT LJT BARD ACCESS SYSTEMS INC. 1708061 REWF1090

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention