BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECTON-DICKINSON VISITEC

    MDR report key: 2171886 · Received June 5, 2006

    Report

    Report Number
    2171886
    Event Type
    Injury
    Date Received
    June 5, 2006
    Date of Event
    May 22, 2006
    Report Date
    May 23, 2006
    Manufacturer
    BECTON-DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 30 GAUGE CANNULA CONNECTED TO A 3 ML LEUR LOCK SYRINGE PREVIOUSLY USED IN THE SAME CATARACT SURGERY TO PERFORM HYDRO-DISSECTION USING BSS (BASIC SALT SOLUTION) ON THE PT. THE CANNULA WAS REMOVED AND THE SYRINGE REFILLED WITH BSS AND THE CANNULA REATTACHED. DURING INJECTION OF THE BSS INTO THE PT'S EYE, THE CANNULA DISENGAGED FROM THE SYRINGE AND ENTERED INTO THE EYE AND THROUGH THE IRIS. CURRENTLY BEING EVALUATED FOR RETINAL TEAR AND DISLOCATION OF IOL THAT MAY HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON-DICKINSON VISITEC 30 GAUGE CANNULA FMI BECTON-DICKINSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention BSS (BASIC SALT SOLUTION)| 3ML LEUR-LOCK SYRINGE FROM BECTON-DICKENSON.