BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE

    MDR report key: 2041198 · Received March 29, 2011

    Report

    Report Number
    2032228-2011-00001
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 29, 2011
    Manufacturer
    AVALON LABORATORIES LLC
    Product Code
    DWF
    PMA / PMN Number
    0810820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORT PROVIDED BY THE USER, "CANNULA WAS POSITIONED TOO HIGH/WAS TOO SHORT TO REACH THE IVC (INFERIOR VENA CAVA) NOT DEEP ENOUGH AND SLIPPED IN TO THE RIGHT ATRIUM COMPRESSING THE RCA (RIGHT CORONARY ARTERY). THE CATHETER WORKING LENGTH IS IDENTIFIED IN PAGE TWO OF AVALON LABS INFORMATION FOR USE P/N 26904. THE 27FR BI-CAVAL LUMEN CATHETERS ARE INSPECTED 100% IN PRODUCTION. THE IFU WARNS THAT INCORRECT INSERTION CAN DAMAGE THE VESSELS AND/OR HEART STRUCTURES.

    Description of Event or Problem · 1

    CANNULA WAS POSITIONED TOO HIGH/WAS TOO SHORT TO REACH THE IVC (INFERIOR VENA CAVA) NOT DEEP ENOUGH AND SLIPPED IN TO THE RIGHT ATRIUM COMPRESSING THE RCA (RIGHT CORONARY ARTERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE 27FR. ELITE BI-CAVAL DUAL LUMEN CATHETER DWF AVALON LABORATORIES LLC 27FR AVALON ELITE 1011-2141172

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening