MAUDE Adverse Event Report: COVIDIEN SHILEY 8.0; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Patient had a tracheostomy placed, cuff leak noted and patient had tracheostomy exchange completed.Another cuff leak noted; patient had second tracheostomy exchanged.Fda safety report id# (b)(4).

• Brand Name: SHILEY 8.0
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13334160
• MDR Text Key: 284448960
• Report Number: MW5106898
• Device Sequence Number: 1
• Product Code: JOH
• 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: 01/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female