BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENUOUS RETURN CANNULA

    MDR report key: 902533 · Received August 21, 2007

    Report

    Report Number
    6000002-2007-50710
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Report Date
    August 14, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN TIGHTENED THE PURSE STRINGS, THE CANNULA WAS CUT IN HALF. THE CANNULA WAS HOLDING BY A WIRE. WHEN IT WAS REMOVED, THE PHYSICIAN WAS ABLE TO CUT THE CANNULA AGAIN BY USING THE PURSE STRINGS. IT APPEARED BRITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENUOUS RETURN CANNULA CANNULA DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL TF33430 58224278

    Patients

    Seq Age Sex Outcome Treatment
    1 YR