BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL

    MDR report key: 2771592 · Received September 26, 2012

    Report

    Report Number
    MW5027106
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND INSTRUMENT THAT WAS OPENED FOR THIS CASE. ACCORDING TO THE STAFF, "THE BLUE DILATOR HAS NO OPENING AT THE END." THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL AGB+ MULTI-LUMEN CVC KIT FOZ ARROW INTERNATIONAL CDC-45703-B1A RF2057494

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR