BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BAS

    MDR report key: 2850683 · Received November 20, 2012

    Report

    Report Number
    3006260740-2012-00418
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 31, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    FOUND DISLODGED CATHETER FROM THE CATHETER LOCK AND THE DISLODGED CATHETER MIGRATED INTO THE HEART. THE MIGRATED CATHETER WAS FOUND AT PULMONARY ARTERY BY X-RAY. THE MIGRATED CATHETER DID NOT SEEM TO BE BROKEN WHEN THE X-RAY CHECK WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BAS LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention