BEUDAMED
    FDA Adverse Event Summary report: N

    JACKSON IMPROVED

    MDR report key: 1846745 · Received September 21, 2010

    Report

    Report Number
    1846745
    Date Received
    September 21, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 21, 2010
    Manufacturer
    SPECTRUM SURGICAL SUPPLIES
    Product Code
    BTO
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SIZE 8 JACKSON TRACHEOSTOMY TUBE CHANGED OUT DUE TO INABILITY TO REMOVE INNER CANNULA. MD WAS AT BEDSIDE TO PERFORM CHANGE OUT OF TRACH. PATIENT TOLERATED PROCEDURE WELL WITH NO COMPLICATIONS. WE BELIEVE THAT POSSIBLY SECRETIONS SEEPED BETWEEN THE INNER CANNULA AND THE OUTER CANNULA, CAUSING THE INNER CANNULA TO BECOME STUCK AND NOT ABLE TO BE REMOVED FOR CLEANING. OUR POLICY IS TO CLEAN THE INNER CANNULA DURING EVERY SHIFT AT LEAST ONCE (AT LEAST ONCE EVERY 8 TO 12 HOURS).======================HEALTH PROFESSIONAL'S IMPRESSION======================INNER CANNULA WAS STUCK TO OUTER CANNULA.======================MANUFACTURER RESPONSE FOR JACKSON TRACHEOSTOMY TUBE, JACKSON IMPROVED======================NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON IMPROVED TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SPECTRUM SURGICAL SUPPLIES 34-918 *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR