BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE

    MDR report key: 245924 · Received September 13, 1999

    Report

    Report Number
    2029387-1999-00058
    Event Type
    Malfunction
    Date Received
    September 13, 1999
    Report Date
    July 17, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECARE PT EXPERIENCED DIFFICULTIES WITH ATTACHING AND MAINTAINING A SECURE INNER/OUTER CANNULA CONNECTION WITH USE OF MULTIPLE SIZE 6 DIC, DISPOSABLE INNER CANNULA DISPOSABLE INNER CANNULA AND ONE (1) SIZE 6 DCT, DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. LIMITED INFO WAS PROVIDED REGARDING THE LENGTH OF TIME THE DEVICES WERE IN USE, WHAT TYPE OF DEVICE MAINTENANCE AND CARE WAS PERFORMED AND WHAT TYPE OF RESPIRATORY CIRCUITRY WAS INVOLVED. THERE WAS NO REPORTED PT INJURY. THE INVOLVED 6 DCT DEVICE AND SEVERAL 6 DIC ACCESSORY DEVICES WERE REPORTEDLY DISCARDED AND AS SUCH ARE NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. TWELVE (12) DIC ACCESSORY DEVICES WERE RETURNED ON 03/08/1999 TO THE MFR FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. DEVICE EVAL RESULTS ARE RECORDED IN SECTION H.10 OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 DIC & 6 DCT M87629000;M86295000;M86624000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN VENTILATORS,| CONNECTORS (MFR AND MODEL TYPES UNKNOWN).| VARIOUS RESPIRATORY ADAPTORS,