BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA FENESTR

    MDR report key: 226619 · Received May 26, 1999

    Report

    Report Number
    2029387-1998-00137
    Event Type
    Malfunction
    Date Received
    May 26, 1999
    Date of Event
    September 25, 1998
    Report Date
    October 30, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL SIZE 8 DIC, DISPOSABLE INNER CANNULA COULD NOT BE INSERTED INTO ONE (1) SIZE 8 DFEN, DISPOSABLE CANNULA FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. THE REPORTER STATES THAT THIS RESULTED IN A CHANGE IN VENTILATION TREATMENT. THE 8 DFEN WAS CAPPED OFF AND PATIENT WAS HOOKED TO A NASAL CANNULA. THERE WERE NO REPORTED PATIENT INJURIES. THE INVOLVED SIZE 8 DFEN AND 8 DIC DEVICES ARE REPORTEDLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. AS OF THE DATE OF THIS REPORT, THE DEVICES HAVE NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA FENESTR TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8 DFEN/8DIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN