MAUDE Adverse Event Report: COVIDIEN SHILEY; #6 TRACHEOSTOMY TUBE

Model Number 6DCT

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Information (3190)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

Covidien shiley #6 tracheostomy tube (cuffed) package did not include the obturator or the inner cannula.Reason for use: placement of tracheostomy tube.

• Brand Name: SHILEY
• Type of Device: #6 TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 5340873
• MDR Text Key: 35007882
• Report Number: MW5058816
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

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: 09/30/2019
• Device Model Number: 6DCT
• Device Catalogue Number: 6DCT
• Device Lot Number: 1410817JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR