BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL INSTRUMENT LUBRICANT

    MDR report key: 4993002 · Received August 3, 2015

    Report

    Report Number
    MW5055268
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    CYGNUS
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    STERILE PROCESSING NOTICED A BLACK SUBSTANCE IN THE CYGNUS MEDICAL INSTRUMENT LUBRICANT. EPIDEMIOLOGY AND MICROBIOLOGY WERE NOTIFIED. TESTS OF THE SUBSTANCE IDENTIFIED HYPHE AS WELL AS BACTERIAL GROWTH. NO PATIENT INVOLVED. DATES OF USE: CAUGHT PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506051 MEDICAL INSTRUMENT LUBRICANT MEDICAL INSTRUMENT LUBRICANT FSM CYGNUS 6203

    Patients

    Seq Age Sex Outcome Treatment
    1