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

Model Number	18875
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per reporting staff, after intubation, it was noted that the air cuff was not holding air.Patient required emergent reintubation.Tube changed out using glidescope and bougie.At no time was the patient desaturating.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP; 200 medtronic dr; lafayette CO 80026
• MDR Report Key: 25763174
• Report Number: 25763174
• Device Sequence Number: 10471500
• Product Code: BTR
• UDI-Device Identifier: 40884521032539
• UDI-Public: (01)40884521032539
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/01/2026
• Report Date (Section F): 07/01/2026

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: 18875
• Device Catalogue Number: 18875
• Device Lot Number: 25L0225JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/01/2026