BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 248818 · Received November 2, 1999

    Report

    Report Number
    2029387-1999-00079
    Event Type
    Malfunction
    Date Received
    November 2, 1999
    Report Date
    October 28, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REOCCURRING PROBLEMS ARE BEING ENCOUNTERED WITH THE SEAL, FIT AND ATTACHMENT OF MULTIPLE SIZE 6 DIC, DISPOSABLE INNER CANNULAE TO THE VENTILATOR CIRCUITRY. LIMITED INFO IS AVAILABLE REGARDING THE EVENTS, THE PTS(S), AND DEVICE USAGE/MAINTENANCE. TWO(2), SIZE 6 DIC DEVICES WERE RETURNED TO THE MFR ON 04/09/99 FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 DIC M90759000, UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN