BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K

    MDR report key: 3180107 · Received June 13, 2013

    Report

    Report Number
    3006260740-2013-00298
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REVJ0773 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED: AFTER SIX MONTHS FROM THE IMPLANT THE CATHETER SLIPPED AWAY FROM THE SURECUFF. CUFF REMAINED ENGLOBED AND REMOVED SURGICALLY, PLACED ANOTHER PRODUCT. THE PT SEEMS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269602 HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K MSD C. R. BARD INC. (BASD) REVJ0773

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention