BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY CUFFLESS FENESTRATED TRACHEOSTOMY TUBE

    MDR report key: 114179 · Received August 18, 1997

    Report

    Report Number
    2029387-1997-00111
    Event Type
    Malfunction
    Date Received
    August 18, 1997
    Report Date
    June 6, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENGTH OF THE INNER CANNULAE WAS INCORRECT AND PROTRUDED THE DISTAL END OF THE OUTER CANNULA. THIS WAS DETECTED ON SIX SIZE 4CFN, CUFFLESS FENESTRATED TRACHEOSTOMY TUBES. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN USE WHEN THE REPORTED PROBLEM WAS DETECTED. LIMITED INFO AVAILABLE/PROVIDED REGARDING PT, EVENT AND DEVICE USAGE. ADDITIONAL INFO HAS BEEN REQUESTED THERE WAS ONE PT INVOLVED WITH NO REPORTED PT COMPROMISE. THE DEVICES WERE REC'D BY THE MFR ON 6/23/97 AND PROCESSED FOR DECONTAMINATION, TESTING AND INVESTIGATION. IS THE EVENT FREQUENCY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OCCURING MORE FREQUENTLY THAN USUAL FOR PRODUCT? NO. IS THE EVENT SEVERITY ADDRESSED IN PRODUCT LABELING? NO. IF "NO", IS EVENT OF GREATER SEVERITY THAN USUAL FOR PRODUCT? NO. THIS MEDICAL DEVICE REPORT IS SUBMITTED IN COMPLIANCE WITH 21 CFR PART 803. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT A MALLINCKRODT DEVICE IS DEFECTIVE OR HAS MALFUNCITONED OR THAT A MALLINCKRODT DEVICE HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS FENESTRATED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 4CFN 9495261600;M402069000;(MORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN