BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GFI TUBING SET

    MDR report key: 312716 · Received May 7, 2001

    Report

    Report Number
    1644019-2001-00003
    Event Type
    Malfunction
    Date Received
    May 7, 2001
    Report Date
    August 22, 2000
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER RETURNED SAMPLE WITH "DEFECTIVE" WRITTEN ON THE LID OF THE TRAY, WITH THE DATE 07/26/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20973 GFI TUBING SET FLUID/GAS EXCHANGE SET HQE ALCON - HOUSTON GFI 63072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA