BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS TWO-STAGE CATHETER

    MDR report key: 1850549 · Received July 7, 2010

    Report

    Report Number
    8010762-2010-14110
    Event Type
    Malfunction
    Date Received
    July 7, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K013944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY AG, (B)(4). MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. MFR REPORT #: 8010762-14110. (B)(4). ADDITIONAL INFO FROM USER FACILITY REPORT: MAQUET CARDIOVASCULAR IS SUBMITTING AN ADDITIONAL INITIAL REPORT AS THE UF/IMPORTER REPORTER. THE UF/IMPORTER REPORT NUMBER WAS ADDED TO THE FORM AND THE MFR REPORT NUMBER WAS REMOVED.

    Description of Event or Problem · 1

    THE BODY OF THE CATHETER WAS NOT CORRECTLY GLUED. THE FAILURE WAS NOTICED DURING UNPACKING PRIOR TO USE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS TWO-STAGE CATHETER CATHETER DWF MAQUET CARDIOPULMONARY AG NA 92021349

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other