BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST STEP BEDSIDE KIT

    MDR report key: 6957788 · Received October 18, 2017

    Report

    Report Number
    6957788
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 29, 2017
    Manufacturer
    CYGNUS MEDICAL
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO OF THE KITS WITH LOT 20171209A HAD EXTREMELY VISCOUS FLUID AND TWO OF THE KITS HAD EXTREMELY VISCOUS FLUID AND BROWN PARTICLES. THE SPONGE IN ANOTHER KIT (LOT NUMBER 20180520A) HAD BLACK SPOTS SCATTERED ON IT. PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739637 FIRST STEP BEDSIDE KIT ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL CYGNUS MEDICAL 20171209A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER DEVICES USED.