BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL ARTERIAL CANNULA

    MDR report key: 36010 · Received August 22, 1996

    Report

    Report Number
    1713910-1996-00019
    Event Type
    Malfunction
    Date Received
    August 22, 1996
    Date of Event
    July 11, 1996
    Report Date
    August 22, 1996
    Manufacturer
    RESEARCH MEDICAL INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FEMORAL CANNULA CONTAINED IN FEM-020 PERCUTANEOUS ACCESS KIT, WAS DISCOVERED PRIOR TO USE, HAVING A CRACKED 3/8" STRAIGHT CONNECTOR. THE UNIT IS BEING RETURNED AND EVENT WILL BE FURTHER EVALUATED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL ARTERIAL CANNULA ARTERIAL CANNULA DQR RESEARCH MEDICAL INC. NA 90D056-1

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other