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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/29/2021

Event Type  Injury  

Event Description

An 8 shiley trach was found to be broken and had to be emergently replaced.Fda safety report id# (b)(4).

• Brand Name: SHILEY TRACHEOSTOMY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 11929962
• MDR Text Key: 254808343
• Report Number: MW5101687
• Device Sequence Number: 1
• Product Code: BTO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: 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: 47 YR
• Patient Weight: 161