MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35216
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient intubated.Multiple times during the day, the patient became disconnected from the vent.The ventilator tubing would spontaneously come apart from the endotracheal tube.Upon further investigation with respiratory therapy, it was found that the end of the 8.0 tube was stretched out from heat.

• Brand Name: AVANOS
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16688932
• Report Number: 16688932
• Device Sequence Number: 12282052
• Product Code: BTR
• UDI-Device Identifier: 00609038352169
• UDI-Public: (01)00609038352169
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/15/2023
• Report Date (Section F): 03/15/2023

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: 35216
• Device Catalogue Number: 35216
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• 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 Sex: Female
• Patient Weight: 108 KG
• Date Report Sent to FDA: 03/15/2023