BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION

    MDR report key: 7494368 · Received May 8, 2018

    Report

    Report Number
    7494368
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 2, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    NXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN NURSES PERFORM ORAL CARE FOR PATIENTS, THE SPONGES OF THE GREEN SUCTION SWABS FELL OFF INTO PATIENTS' MOUTHS. THIS EVENT HAPPENED ON THE MULTIPLE DAYS. MANUFACTURER RESPONSE FOR ORAL CARE PRODUCTS, 24 HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION (PER SITE REPORTER): MEDLINE'S PRODUCT QUALITY TEAM DID INSPECTION ON THEIR SUCTION SWABS IN THE FACTORY AND ADDED EXTRA GLUE TO THE SWAB IN THE MANUFACTURING PROCESS. THEY REPLACED OUR STOCK WITH NEW LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339721 24HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION ORAL CARE PRODUCTS NXZ MEDLINE INDUSTRIES INC 18-039-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES