BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIO KIT

    MDR report key: 2268245 · Received September 8, 2011

    Report

    Report Number
    2268245
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 8, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    OEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIO KIT WAS OBTAINED. KIT IN PACKAGE. STAFF NOTICED VALVE BROKEN BEFORE THE PACKAGE WAS OPENED. TIP BROKEN AWAY FROM TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIO KIT KIT, CANNULA, CARDIAC OEU MEDTRONIC, INC. DLP2X23R4 11516086

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES