BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 16313612 · Received February 7, 2023

    Report

    Report Number
    1417592-2023-00045
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 24, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGV
    UDI-DI
    10080196032914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, SHE NOTICED DAMAGE TO THE INSIDE OF HER TRACHEOSTOMY TUBE, SHE REPORTS "THE METAL DAMAGED THE INSIDE TRACH AND SPLIT IT APART." ACCORDING TO THE CUSTOMER, OVER TIME THE BRUSH CAUSED THIS TO OCCUR BECAUSE THEY ARE "HARD AND NOT FLEXIBLE." SHE REPORTS DUE TO THIS, SHE WILL NEED TO HAVE THE TUBE REPLACED BY HER DOCTOR. CUSTOMER REPORTS SHE USES THE BRUSHES ONE TIME AND THEN DISPOSES OF THEM. THE SAMPLE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, SHE NOTICED DAMAGE TO THE INSIDE OF HER TRACHEOSTOMY TUBE, SHE REPORTS "THE METAL DAMAGED THE INSIDE TRACH AND SPLIT IT APART". ACCORDING TO THE CUSTOMER, OVER TIME THE BRUSH HAS CAUSED THIS TO OCCUR BECAUSE THEY ARE "HARD AND NOT FLEXIBLE". SHE REPORTS DUE TO THIS, SHE WILL NEED TO HAVE THE TUBE REPLACED BY HER DOCTOR. CUSTOMER REPORTS SHE USES THE BRUSHES ONE TIME AND THEN DISPOSES OF THEM. A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DAMAGE TO TRACH REQUIRING TUBE TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927594 MEDLINE TRAY,TRACH,MINI,NO GLOVES,NONSTERILE OGV MEDLINE INDUSTRIES, LP DYND40622 10-6052208009 10080196032914

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other