BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRESS-WAY RX CATHETER,6F

    MDR report key: 5021822 · Received August 21, 2015

    Report

    Report Number
    1219977-2015-00237
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 28, 2015
    Report Date
    July 28, 2015
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED STATED THE CATHETER CAME OFF THE WIRE AFTER BEING PLACED IN THE BODY. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556253 XPRESS-WAY RX CATHETER,6F CATHETER DXE KANEKA PHARMA AMERICA LLC T2R6SA4A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention