FDA Adverse Event Summary report: N

JACKSON IMPROVED

MDR report key: 1846744 · Received September 21, 2010

Report

Report Number
1846744
Date Received
September 21, 2010
Date of Event
August 9, 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 BEEN ON RESPIRATORY CARE'S SERVICE FOR A WEEK FOR TRACH CARE. INITIATED PROTOCOL FOR PATIENT DISCHARGE ON THE DAY OF THE EVENT. FOUND PATIENT'S INNER CANNULA, SIZE 6 METAL JACKSON TRACHEOSTOMY TUBE, WAS STUCK TO OUTER CANNULA, AND COULD NOT BE REMOVED FOR CLEANING. PATIENT WAS SUCTIONED AND AIRWAY WAS DEEMED PATENT. ASSISTANCE WAS REQUESTED AND 2 ADDITIONAL THERAPISTS RESPONDED AND COULD NOT REMOVE INNER CANNULA SUCCESSFULLY. DR WAS CALLED TWICE AND AGREED TO COME IN TO REPLACE THE TRACH, SO A REPLACEMENT TRACH WAS ORDERED. EMS EMERGENCY MEDICAL SERVICE WAS PRESENT TO TAKE PATIENT TO AN ECF EXTENDED CARE FACILITY UPON DISCHARGE FROM HOSPITAL, BUT COULD NOT DUE TO UNSTABLE AIRWAY AND SAFETY ISSUE. DR REPLACED TRACH DURING THE AFTERNOON AND EMS WAS CALLED AND PATIENT DISCHARGED AT APPROXIMATELY 3 HOURS LATER ON THE DAY OF THE EVENT. CLINICAL ENGINEERING BELIEVES THAT THERE MAY BE A DESIGN ISSUE WITH THIS "JACKSON IMPROVED" STYLE OF TRACH TUBE, WHERE SECRETIONS CAN SEEP IN BETWEEN THE INNER AND OUTER CANNULA AND HARDEN, THEREBY MAKING IT DIFFICULT TO REMOVE THE INNER CANNULA FOR CLEANING. A SIMILAR INCIDENT OCCURRED ON 2 OTHER PATIENTS IN THE LAST MONTH.======================HEALTH PROFESSIONAL'S IMPRESSION======================PATIENT WAS NOT COMPLIANT WITH WEARING TRACH HUMIDITY SETUP DESPITE RESPIRATORY THERAPISTS EXPLAINING THE NEED FOR IT AND ENCOURAGING PATIENT TO WEAR IT.======================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 34-916 *

Patients

Seq Age Sex Outcome Treatment
1 71 YR