BEUDAMED
    FDA Adverse Event Summary report: N

    JACKSON IMPROVED

    MDR report key: 1846743 · Received September 21, 2010

    Report

    Report Number
    1846743
    Date Received
    September 21, 2010
    Date of Event
    August 24, 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

    PATIENT HAD SIZE 5 JACKSON METAL TRACHEOSTOMY WITH WHEEL-STYLE INNER CANNULA PLACED. RESPIRATORY CARE CALLED TO BEDSIDE FOR TRACH SITE CARE THE DAY AFTER PLACEMENT OF THE TRACH. UNABLE TO REMOVE INNER CANNULA FOR CLEANING - IT APPEARED THAT THE INNER CANNULA WAS FUSED IN PLACE. COULD NOT REMOVE INNER CANNULA WITHOUT INJURY TO PATIENT. CLINICAL ENGINEERING NOTIFIED OF PROBLEM--4TH INSTANCE OF THIS PROBLEM AT THIS INSTITUTION IN THIS YEAR. DR FROM SICU SURGICAL INTENSIVE CARE UNIT NOTIFIED IMMEDIATELY FOR TRACH TUBE CHANGE AT BEDSIDE. PATIENT WAS UNHARMED, BUT HAD DELAYED DISCHARGE DUE TO TRACH TUBE NEEDING TO BE CHANGED OUT. CLINICAL ENGINEERING BELIEVES THERE MAY BE A DESIGN ISSUE WITH THIS "JACKSON IMPROVED" STYLE OF TRACH TUBE, WHERE SECRETIONS CAN SEEP BETWEEN THE INNER AND OUTER CANNULA AND DRY UP, WHICH MAKES IT DIFFICULT TO REMOVE THE INNER 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 34-915 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR