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

Model Number	86451
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient intubated with #7.5 endotracheal tube (ett) for respiratory failure with altered mental status at [time redacted].The ett developed a cuff leak and patient required re-intubation.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 20333112
• Report Number: 20333112
• Device Sequence Number: 15478119
• Product Code: BTR
• UDI-Device Identifier: 30884522000479
• UDI-Public: (01)30884522000479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2024
• Report Date (Section F): 08/28/2024

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: 86451
• Device Catalogue Number: 86451
• Device Lot Number: 24F1151JZX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Date Report Sent to FDA: 08/28/2024