BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE SUCTION SWAB TRAY

    MDR report key: 7453820 · Received April 23, 2018

    Report

    Report Number
    MW5076663
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    April 13, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    NXZ
    UDI-DI
    10888277318625
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ORAL CARE USING MEDLINE ORAL CARE KIT, THE GREEN SPONGE EASILY FELL OFF THE SUCTION STICK AND WAS IN THE BACK OF PT'S MOUTH. PT IS INTUBATED AND HAS ETAD WITH BUILT IN BITE BLOCK. PT ALSO SEDATED AT THIS TIME AND NOT BITING OR MOVING WITH ORAL CARE. GENTLE SWABBING OF TONGUE WAS BEING PERFORMED WHEN NOTICED SPONGE HAD FALLEN. IMMEDIATELY REMOVED GREEN SPONGE FROM BACK OF MOUTH WITH YANKAUER AND ASSISTANCE BY RN WITH PEN LIGHT. FULL PIECE WAS REMOVED AND NO OTHER PIECE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295830 MEDLINE SUCTION SWAB TRAY DENTAL HYGIENE KIT NXZ MEDLINE INDUSTRIES INC. 18-043-02 10888277318625

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other