MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN MEDTRONIC SHILEY ENDOTRACHEAL TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Gas/Air Leak (2946)

Patient Problem Pneumothorax (2012)

Event Date 07/29/2020

Event Type  Injury  

Event Description

Ett cuff developed sudden cuff leak was unable to hold pressure.Required emergent change of ett.Patient subsequently developed 100% right pneumothorax, believed to be associated with event linked barotrauma.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC SHILEY ENDOTRACHEAL TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC/COVIDIEN; mansfield MA 02048
• MDR Report Key: 10367299
• MDR Text Key: 201896209
• Report Number: MW5095892
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 88