BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE INNER CANNULA

    MDR report key: 113464 · Received August 15, 1997

    Report

    Report Number
    2029387-1997-00106
    Event Type
    Malfunction
    Date Received
    August 15, 1997
    Date of Event
    May 1, 1997
    Report Date
    June 19, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECURE CONNECTION COULD NOT BE MAINTAINED ON TEN (10), SIZE 8 DIC, DISPOSABLE INNER CANNULAE AND SEVERAL VENTILATOR CIRCUIT ELBOW ADAPTORS. THE ATTENDING HOMECARE NURSE VISUALLY OBSERVED THAT THE 15 MM CONNECTOR OF THE DIC APPEARED OVERSIZED. THE 8DIC'S AND VENTILATOR ADAPTOR WOULD DISCONNECT IMMEDIATELY TO SIXTEEN HRS. AFTER ATTACHMENT. THERE WAS ONE (1) PT INVOLVED WITH NO REPORTED PT COMPROMISE. ONLY THREE (3) OF THE 8DIC ACCESSORY COMPONENTS ARE AVAILABLE TO BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION. AS OF THE DATE OF THIS SUBMISSION THE 8DIC'S HAVE NOT BEEN RECEIVED BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8DIC M65268000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR LIFECARE CIRCUIT ELBOW ADAPTOR.