MAUDE Adverse Event Report: COVIDIEN SHILEY; SHILEY CUFFED TRACHESOTOMY

Catalog Number 8DCT

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

The cuff of the tracheostomy was leaking air.This is the 3rd patient with this same problem (with the same type of device) within a short period of time (approximately 1 month).At this time it is unclear whether there is an issue with the product versus a user or surgical issue.

• Brand Name: SHILEY
• Type of Device: SHILEY CUFFED TRACHESOTOMY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 4454392
• MDR Text Key: 5424002
• Report Number: MW5040392
• Device Sequence Number: 1
• Product Code: JOH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/12/2015
• 3 Devices were Involved in the Event: 1 2 3

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
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 8DCT
• Device Lot Number: 14D0193JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR