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

Model Number	8CN85A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Noted air leak in trach.Trach balloon tested by the surgery team.The balloon had a slight egg shape rather than a spherical one.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN LP; 200 medtronic dr; lafayette CO 80026
• MDR Report Key: 24814944
• Report Number: 24814944
• Device Sequence Number: 6146275
• Product Code: JOH
• UDI-Device Identifier: 10884521172494
• UDI-Public: (01)10884521172494
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/01/2026
• Report Date (Section F): 04/01/2026

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 Model Number: 8CN85A
• Device Lot Number: K0388JZX
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 04/01/2026