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

Lot Number 21A830JZX

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Surgeon inserted 8 cuffed shiley without difficulty, inflated cuff and sutured in place.Surgeon started working on hemilaryngectomy procedure when he noticed leak with anesthesia gas, placed new trach tube after noticing cuff would not reinflate.After inserting second trach tube cuff would not inflate either and md stated there was a small hole in cuff.Third cuff inflated without difficulty and no leak.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN SHILEY CUFFED TRACH TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12180606
• MDR Text Key: 262223200
• Report Number: MW5102575
• 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: 07/13/2021
• 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
• Device Lot Number: 21A830JZX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2021
• 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: 77 YR
• Patient Weight: 109