BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPLIT 14.5 FR, ST, 19CM KIT

    MDR report key: 507997 · Received January 21, 2004

    Report

    Report Number
    1720496-2004-00015
    Event Type
    Injury
    Date Received
    January 21, 2004
    Report Date
    January 13, 2004
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS IS THE FIRST TIME THE DR HAS USED THE CATHETER. HE HAD IMPLANTED AN INTRODUCER AND WENT TO PLACE THE OTG WIRE AND WHEN RESISTANCE WAS FELT, PULLED BACK AND THEN CONTINUED THE OTG TUNNELING. THE WIRE WAS KINKED BUT NOT SURE IF FROM THE RESISTANCE OR FROM MFR. THE DR THINKS THE WIRE PERFORATED THE LUNG. THE PT HAS SUFFERED HEMO. PT IS CURRENTLY IN ICU WITH CARDIAC TAMPONADE. A CARDIAC SURGEON HAS BEEN CONTACTED FOR THIS CASE. PT INJURY INDICATED.

    Description of Event or Problem · 1

    THIS IS THE FIRST TIME THE DR HAS USED THE CATHETER. DR HAD IMPLAINT AN INTRODUCER WHEN TO PLACE THE OTG WIRE AND WHEN RESISTANCE WAS FELT, PULLED BACK AND THEN CONTINUED THE OTG TUNNELING. THE WIRE WAS KINKED BUT NOT SURE IF FROM THE RESISTANCE OR FROM MFR. THE DR THINKS THE WIRE PERFORATED THE LUNG. THE PT HAS SUFFERED HEMO. PT IS CURRENTLY IN ICU WITH CARDIAC TAMPONADE. A CARDIAC SURGEON HAS BEEN CONTACTED FOR THIS CASE. PT INJURY INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSPLIT 14.5 FR, ST, 19CM KIT IMPLANTED BLOOD ACCESS DEVICE MSD BARD REYNOSA S.A. DE C.V. 5703690 22JN7392

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening