BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    55 CM 5 FR. D/L GROSHONG NXT UPFT WITH MI AND TLS

    MDR report key: 1930441 · Received November 18, 2010

    Report

    Report Number
    3006260740-2010-00346
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 3, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PICC LINE FLUSHED W/ NO ISSUES. ONE UNIT OF PRBCS HUNG. ONE HOUR LATER, NOTICED BLOOD ON PT'S GOWN/PILLOW. PICC REMOVED AND LEAK AT 20CM MARK WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 55 CM 5 FR. D/L GROSHONG NXT UPFT WITH MI AND TLS LJS C. R. BARD INC. (BASD) REUE0025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention