BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFI TUBING SET

    MDR report key: 31242 · Received March 14, 1996

    Report

    Report Number
    MW1008638
    Event Type
    Injury
    Date Received
    March 14, 1996
    Date of Event
    March 6, 1996
    Report Date
    March 7, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN CIRCULATING NURSE ATTEMPTED TO SPIKE A 500CC BOTTLE OF EYE IRRIGATION, THE AIR FILTER, WHICH WAS ALREADY PRIMED, CRACKED, CAUSING AIR TO INFILTRATE SYSTEM. THIS CAUSED EYE TO COLLAPSE. UNKNOWN IF THERE IS ANY PERMANENT PROBLEM. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFI TUBING SET TUBING SET KYG ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention