BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRESS-WAY RX CATHETER, 6FR

    MDR report key: 6251139 · Received January 13, 2017

    Report

    Report Number
    3011175548-2017-00002
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 28, 2016
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USING THE FILTER, THE CUSTOMER RINSED THE FIRST FILTER. DESPITE RINSING ALL FOUR COMPARTMENTS AT LEAST TWO OF THE THREE FILTERS WERE CLOGGED AND WOULD NOT DRAIN.

    Description of Event or Problem · 1

    PRIOR TO USING THE FILTER, THE CUSTOMER RINSED THE FIRST FILTER. DESPITE RINSING ALL FOUR COMPARTMENTS AT LEAST TWO OF THE THREE FILTERS WERE CLOGGED AND WOULD NOT DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33575 XPRESS-WAY RX CATHETER, 6FR CATHETER, EMBOLECTOMY DXE KANEKA PHARMA AMERICA LLC T2R6SA4A KPO86531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention