BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM-FLEX FEMORAL CANNULA

    MDR report key: 92351 · Received May 12, 1997

    Report

    Report Number
    1713910-1997-00009
    Event Type
    Malfunction
    Date Received
    May 12, 1997
    Date of Event
    April 16, 1997
    Report Date
    May 9, 1997
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    LFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING INSERTION OF THE CANNULA, WHEN THE CAP WAS BEING PLACED, THE CCP NOTICED THE LUER PORTION OF THE T-CONNECTOR WAS CRACKED. THE CANNULA WAS USED FOR REMAINDER OF PROCEDURE WITH NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEM-FLEX FEMORAL CANNULA FEMORAL ARTERIAL CANNULA LFK RESEARCH MEDICAL, INC. * 88404

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R