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

Model Number	86450
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During code blue: after intubation, provider discovered the et tube was malfunctioning.Tube was removed and reportedly had a crack in it.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10816369
• Report Number: 10816369
• Device Sequence Number: 19856024
• Product Code: BTR
• UDI-Device Identifier: 30884522000462
• UDI-Public: (01)30884522000462(17)2503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/13/2020
• Report Date (Section F): 10/13/2020

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: Health Professional
• Device Model Number: 86450
• Device Catalogue Number: 86450
• Device Lot Number: 20C0476JZX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54
• Date Report Sent to FDA: 10/13/2020