BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 2013787 · Received February 4, 2011

    Report

    Report Number
    1036844-2011-00039
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW HOURS AFTER THE CATHETER WAS INDWELLED, BLOOD LEAKED AROUND THE HANDLE OF THE STOPCOCK. AS A RESULT, THE STOPCOCK ONLY WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTERNATIONAL, INC. RF0074518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN