BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 232800 · Received May 18, 1999

    Report

    Report Number
    2029387-1999-00042
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Date of Event
    January 28, 1999
    Report Date
    May 10, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INFLATION COULD NOT BE MAINTAINED ON ONE (1) SIZE 7 SCT, SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE. THE DEVICE WAS REMOVED AND REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THE INVOLVED 7 SCT DEVICE HAD BEEN IN USE APPROXIMATELY ONE (1) WEEK. THERE WAS ONE PATIENT INVOLVED WITH NO REPORTED PATIENT INJURY. THE 7 SCT DEVICE WAS RETURNED TO THE MFR ON 03/18/1999 FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. THE MANUFACTURERS DEVICE EVAL RESULTS ARE RECORDED ON SECTION H OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 7 SCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention