BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG 9.5 FR D/L CV CATHETER

    MDR report key: 1033696 · Received April 25, 2008

    Report

    Report Number
    2523003-2008-00047
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 7, 2008
    Manufacturer
    C.R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K860256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PROD COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    THE LINE WAS PLACED IN 2008, AND WAS REMOVED THE NEXT DAY, BECAUSE THE LINE SHEARED IN 2 PIECES AND MIGRATED. THE MIGRATION PORTION WAS REMOVED FROM THE RIGHT GROIN AREA. PRIOR TO THE BREAK THE LINE WAS FOUND TO BE LEAKING. NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 9.5 FR D/L CV CATHETER FOZ C.R. BARD INC. (BASD) RERI0043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention