MAUDE Adverse Event Report: COVIDIEN #8 CUFFED SHILEY TRACH TUBE

Device Problems Air Leak (1008); Inflation Problem (1310)

Patient Problems Cardiac Arrest (1762); Death (1802); Extubate (2402)

Event Date 11/20/2015

Event Type  Death  

Event Description

Continuous problem with trach cuff leaking air throughout shift air leaking around trach and mouth.This began to occur around 17 hours after placement.#8 cuffed shiley tracheostomy tube.Required intubation, removal of trach, and replacement.Patient arrested during process and expired the following day.Upon inspection of cuff after removal by ent, noticed that cuff would not stay inflated.Dates of use: (b)(6) 2015 - (b)(6) 2015.Diagnosis or reason for use: airway management.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.

• Brand Name: #8 CUFFED SHILEY TRACH TUBE
• Type of Device: #8 CUFFED SHILEY TRACH TUBE
• Manufacturer (Section D): COVIDIEN; marion OH 44302
• MDR Report Key: 5396707
• MDR Text Key: 37083714
• Report Number: MW5059711
• Device Sequence Number: 1
• Product Code: JOH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 81