BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 60194 · Received September 19, 1996

    Report

    Report Number
    2029387-1996-00092
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 22, 1996
    Report Date
    September 19, 1996
    Manufacturer
    MALLINCKRODT MEDICAL, INC
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURVATURE ON TWO SIZE 8 DISPOSABLE INNER CANNULAE (DIC) WAS TOO EXTREME AND THUS WERE IMPOSSIBLE TO INSERT. THE HOME NURSE ON DUTY WAS ALSO UNABLE TO INSERT THE COMPONENTS. A DIFFERENT DIC WAS INSERTED WITHOUT FURTHER INCIDENT. THE PT IS AN END-STAGE ALS PT. NO PT INJURY WAS REPORTED. IT IS UNKNOWN WHETHER EITHER DEVICE INVOLVED WILL BE RETURNED TO THE MFR FOR EVALUATION. HOWEVER, THE USER WILL RETURN SEVERAL UNUSED UNITS FROM THE SAME LOT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC 8DIC M63336000; M63476000

    Patients

    Seq Age Sex Outcome Treatment
    1 *