BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS TWO-STAGE CATHETER

    MDR report key: 1912382 · Received November 23, 2010

    Report

    Report Number
    8010762-2010-18010
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 27, 2010
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K013944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    DURING REMOVING THE CANNULA OF THE RIGHT ATRIUM, THE TIP REMAINED IN THE INTERIOR VENA CAVA. THE HEART LUNG MACHINE WAS STARTED AGAIN TO REMOVE THE CANNULA TIP. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS TWO-STAGE CATHETER CATHETER DWF MAQUET CARDIOPULMONARY AG NA 92029934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other