BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR X 4 (10CM)

    MDR report key: 1592944 · Received January 29, 2010

    Report

    Report Number
    1036844-2010-00024
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 29, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE CATHETER WAS BEING PLACED IN THE PT'S INTERNAL JUGULAR. BEFORE THE SWAN CATHETER WAS INSERTED THE VALVE BEGAN TO LEAK. AS A RESULT, IT WAS REMOVED. ADDITIONAL INFO RECEIVED FROM THE SALES REP ON 1/19/2010 STATES THEY REPLACED THE SHEATH WITH A MULTI-LUMEN ACCESS CATHETER (MAC) INTRODUCER. THERE WERE NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR X 4 (10CM) CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. RF9112522

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SWAN GANZ CATHETER