BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA CUFFLESS FENESTRATED TRACHEOSTOMY

    MDR report key: 141721 · Received January 6, 1998

    Report

    Report Number
    2029387-1997-00175
    Event Type
    Malfunction
    Date Received
    January 6, 1998
    Date of Event
    September 26, 1997
    Report Date
    October 27, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON MULTIPLE OCCASIONS, A HOMECARE PT EXPERIENCED PROBLEMS WITH THE SEAL AND FIT OF THE INNER TO OUTER CANNULAE ON TWO, SIZE 6 DCFN, DISPOSABLE CANNULA CUFFLESS FENESTRATED TRACHEOSTOMY TUBES AND FOUR, SIZE 6 DIC, DISPOSABLE INNER CANNULA DISPOSABLE INNER CANNULAE. THE DEVICES WERE IN USE LESS THAN TWENTY-FOUR HRS WHEN THE REPORTED PROBLEMS OCCURRED. THERE WAS ONE PT INVOLVED WITH NO REPORTED PT COMPROMISE. TWO 6 DCFN DEVICES AND TWO 6 DIC DEVICES WERE RETURNED ON 10/15/97 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA CUFFLESS FENESTRATED TRACHEOSTOMY TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6DCFN & 6DIC M74653000 & UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR VARIOUS CONNECTORS/ADAPTORS (MFR MODEL TYPES UNK)| PB 2800 VENTILATOR