BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGH

    MDR report key: 2903481 · Received January 3, 2013

    Report

    Report Number
    3006260740-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    September 11, 2012
    Report Date
    December 10, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS TO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR IMPLANTED A LONG TERM CATHETER FROM RIGHT INTERNAL JUGULAR IN (B)(6) 2012 FROM THAT TIME TO (B)(6) 2012. HEMODIALYSIS IS SUCCESSFUL. ON (B)(6) 2012, THE DOCTOR FOUND THE PT'S CATHETER OUT OF POSITION 1CM WHEN HE WAS STAYED AT HOME. THE DOCTOR CHECKED AND CONFIRMED THAT THE CUFF WAS STILL IN PT'S BODY. THE CATHETER SEPARATED FROM THE CUFF. THE DOCTOR HAS TO CHANGE A NEW CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351 HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGH MSD C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention