BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER CUTDOWN TRAY WITH SU

    MDR report key: 1993796 · Received January 13, 2011

    Report

    Report Number
    3006260740-2011-00016
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 2, 2010
    Report Date
    January 12, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJT
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR OF HUSH1734 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BROVIAC NOTED TO BE SPLIT BY FATHER OF CHILD. ADMISSION TO HOSPITAL, IV ANTIBIOTICS, WAITED 24 HOURS UNTIL REPAIR KIT OBTAIN. BROVIAC REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 6.6 FR SINGLE-LUMEN CV CATHETER CUTDOWN TRAY WITH SU LJT C. R. BARD INC. (BASD) HUSH1734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention