BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2860044 · Received December 4, 2012

    Report

    Report Number
    3006260740-2012-00447
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    October 28, 2012
    Report Date
    November 23, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K030020
    Product Problem
    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 EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REVG0959 SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2012, THE PATIENT WAS IMPLANTED A LONG TERM DIALYSIS CATHETER. THE SURGERY WAS SUCCESSFUL. 3 TIMES ONE WEEK HEMODIALYSIS IN HOSPITAL (B)(6) 2012. THE PATIENT FOUND THE CATHETER OUT OF BODY PART LONGER THAN BEFORE WHEN HE WAS STAY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSPLIT, 14.5 FR, STANDARD KIT, 19 CM, STRAIGHT MSD C. R. BARD INC. (BASD) REVG0959

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention