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

Model Number	35167
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to pass a bronchoscopy to look for obstructions due to the decline in the patient's o2 levels, the ett was noted to be kinked.

• 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: 13558731
• Report Number: 13558731
• Device Sequence Number: 4456890
• Product Code: BTR
• UDI-Device Identifier: 00609038351674
• UDI-Public: (01)00609038351674
• 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): 02/04/2022
• Report Date (Section F): 02/04/2022

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: 35167
• Device Catalogue Number: 35167
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2022
• 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: Male
• Patient Weight: 50 KG
• Date Report Sent to FDA: 02/04/2022