MAUDE Adverse Event Report: COVIDIEN LP SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 8CN85ER

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Respiratory doing routine check on patient with tracheostomy tube, 8.5 shiley coviden flexible evac trach secure and intact but noticed cuff was deflated.Attempts to reinflate the cuff failed.Responding clinician notified and since it was not first change, respiratory therapist changed to same size and style tracheostomy tube (cuff inflated prior to insertion to confirm intact cuff).Trach tube replaced without incident.Trach tube that was removed had a confirmed leak in the cuff.

• Brand Name: SHILEY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13141564
• MDR Text Key: 283089308
• Report Number: 13141564
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

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 Model Number: 8CN85ER
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 123 KG