BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON GFI TUBING

    MDR report key: 16416 · Received June 17, 1994

    Report

    Report Number
    16416
    Event Type
    Injury
    Date Received
    June 17, 1994
    Date of Event
    June 8, 1994
    Report Date
    June 17, 1994
    Manufacturer
    ALCON LABORATORIES
    Product Code
    KYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GRAVITY FLOW IRRIGATION (GFI) TUBING BLOW-OUT AT FILTER/SPIKE JUNCTION. BSS PLUS WAS DRIPPING ON FLOOR AND AIR ENTERED EYE. PHYSICIAN IS CONCERNED ABOUT POSSIBLE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON GFI TUBING GRAVITY FLOW IRRIGATION TUBING KYG ALCON LABORATORIES 92419

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R