MAUDE Adverse Event Report: MEDTRONIC SHILEY TRACHEOSTOMY TUBE

Model Number 6CN75H

Device Problems Kinked (1339); Suction Problem (2170)

Patient Problem No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

Event Description

Today there was difficulty suctioning him and an attempt to change his inner cannula was performed.There was significant difficulty in placing the cannula and so ent was called.Ent performed a bedside endoscopy through the tube and saw that there was a significant kink creating an obstruction of approx 50% of the tube.Below the tube, the pt was having dynamic tracheomalacia (presumed from the obstruction in the tube).He was taken to the operating room and intubated from above and the tube changed.

• Brand Name: SHILEY TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7302438
• MDR Text Key: 101315986
• Report Number: MW5075568
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6CN75H
• Device Catalogue Number: 6CN75H
• Device Lot Number: 17J0873JZX
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75