BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOGLIDE KIT, PC-2

    MDR report key: 1081050 · Received July 18, 2008

    Report

    Report Number
    3006260740-2008-00045
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K010567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    THE LINE WAS FLUSHED WITH SALINE THROUGH THE ARTERIAL LINE. RESISTANCE WAS EXPERIENCED AND LEAKAGE WAS OBSERVED FROM THE EXIT SITE. PROCEDURE STOPPED AND THE LINE WAS REMOVED THE FOLLOWING DAY. UPON REMOVAL A LEAK WAS OBSERVED IN THE LINE 1CM PAST CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOGLIDE KIT, PC-2 MSD C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention