BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER

    MDR report key: 4847559 · Received June 9, 2015

    Report

    Report Number
    MW5043086
    Event Type
    Injury
    Date Received
    June 9, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 9, 2015
    Manufacturer
    ORIGEN
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN ORIGEN 13FR DUAL LUMEN CATHETER LOT #K17389 WAS USED FOR THE INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. AS THE RUN CONTINUED, THE CATHETER APPEARED TO BECOME UNDONE AT THE HUB WHERE IT IS INSERTED IN THE PATIENT. WHEN DECANNULATED, THE CATHETER WAS SAVED AND THE HUB WAS INSPECTED TO FIND EXPOSED WIRES AND THE "SLEEVE" OF THE CATHETER BECOMING UNDONE. ORIGEN BIOMEDICAL (B)(6) 2015 - (B)(6) 2015. USED CONTINUOUSLY WITH ECMO. DATES OF USE: (B)(6) 2015 - (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369815 ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER DWF ORIGEN M516VV13FO K17389

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening