BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THIN FLEX VENUOUS RETURN CANNULA

    MDR report key: 902530 · Received August 21, 2007

    Report

    Report Number
    6000002-2007-51670
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Report Date
    April 27, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA "BURSTED" DURING PERFUSION (AFTER 1.25 HRS) AND HAD SUCKED IN AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIN FLEX VENUOUS RETURN CANNULA CANNULA DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL TF3343OA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR