BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSS AND BSS PLUS ADMINISTRATION SET

    MDR report key: 308485 · Received December 8, 2000

    Report

    Report Number
    1644019-2000-00038
    Event Type
    Malfunction
    Date Received
    December 8, 2000
    Date of Event
    November 10, 2000
    Report Date
    November 10, 2000
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    Removal / Correction Number
    1644019-112100-002R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED UNITS OF THE SAME LOT NUMBER WERE THOUGHT TO PROVIDE INADEQUATE FLOW OF INFUSION FLUID. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BSS AND BSS PLUS ADMINISTRATION SET OCULAR SURGICAL IRRIGATION DEVICE KYG ALCON - HOUSTON 0065082650 117113H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA