BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATERPILLAR BRUSH

    MDR report key: 795066 · Received December 13, 2006

    Report

    Report Number
    MW1041344
    Event Type
    Malfunction
    Date Received
    December 13, 2006
    Date of Event
    December 5, 2006
    Report Date
    December 13, 2006
    Manufacturer
    CYGNUS MEDICAL
    Product Code
    FDX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BRUSH PART PULLED APART FROM THE LEADER END. RN DIDN'T FEEL LIKE SHE PUSHED VERY HARD. RN HAD GONE IN THROUGH THE SUCTION TIP AND THE BRUSH WAS PARTIALLY IN WHEN IT BROKE OFF. RN WAS ABLE TO PULL BOTH PARTS OUT. PULLED REMAINING BRUSHES FROM SAME BOX AND REPLACED WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATERPILLAR BRUSH BRUSH FDX CYGNUS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *