BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE

    MDR report key: 130708 · Received November 3, 1997

    Report

    Report Number
    2029387-1997-00174
    Event Type
    Malfunction
    Date Received
    November 3, 1997
    Date of Event
    August 1, 1997
    Report Date
    October 9, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA INTERNATIONAL MM FACILITY (GMBH) THAT THE "INNER CANNULA LOOSENS VERY EASILY. SHORT MOVEMENT OF PT SUFFICIENT" ON ONE 6 LPC, LOW PRESSURE CUFFED TRACHEOSTOMY TUBE AND ONE 8 LPC, LOW PRESSURE CUFFED TRACHEOSTOMY TUBE. LIMITED INFO AVAILABLE REGARDING THE REPORTED EVENTS/DEVICES. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN USE OR WHAT TYPE OF MAINTENANCE WAS PERFORMED. THERE WAS NO REPORTED PT COMPROMISES. THE 6 LPC AND THE 8 LPC DEVICES WERE DISCARDED AND AS SUCH WILL NOT BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6LPC/8LPC M72698000;M67217000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN