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

Model Number	86452
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The vent circuit/bvm connector at the top of the endotracheal tube is easily dislodged from the ett itself.Another ett is having to be used or the top of the ett has to be cut in order to keep the connector from coming out of the tube.The respiratory department has reported four that they have encountered in the last month or so.They have all occurred with the 8.0mm tubes however none of the tubes or packing was retained.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7446294
• Report Number: 7446294
• Device Sequence Number: 1769131
• Product Code: BTR
• UDI-Device Identifier: 60884522000487
• UDI-Public: (01)60884522000487
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018
• Report Date (Section F): 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 86452
• Device Catalogue Number: 86452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/10/2018