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

Model Number	86451
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunctioning endotracheal tube (ett) in three different patients on same night shift.Patients were intubated with the ett, and after placement, a cuff leak was identified in each patient.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder CO 80301
• MDR Report Key: 20333170
• Report Number: 20333170
• Device Sequence Number: 9628845
• 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): 08/26/2024
• Report Date (Section F): 08/26/2024

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?: Yes
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Date Report Sent to FDA: 08/26/2024