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

Model Number	86234
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to prepare a 3.0 ett for re intubation.I was trying to pull the hub off to loosen it and the hub broke into 2 pieces.3.0 shiley ett lot 25c0363jzx.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN; 200 medtronic dr; lafayette CO 80026
• MDR Report Key: 23973558
• Report Number: 23973558
• Device Sequence Number: 9152328
• Product Code: BTR
• UDI-Device Identifier: 10884521797260
• UDI-Public: (01)10884521797260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025
• Report Date (Section F): 12/11/2025

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
• Operator of Device: Other
• Device Model Number: 86234
• Device Catalogue Number: 86234
• Device Lot Number: 25C0363JZX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2025