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

Model Number	35161
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient is intubated with a 3.0 ett, tube is secure, sedation is adequate, however any slight movement or cough causes the blue piece of ett to pop of the vent.

• Brand Name: HALYARD
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16120867
• Report Number: 16120867
• Device Sequence Number: 6547939
• Product Code: BTR
• UDI-Device Identifier: 10680651351613
• UDI-Public: (01)10680651351613
• 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): 12/01/2022
• Report Date (Section F): 12/01/2022

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: 35161
• Device Lot Number: CM1141005
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2023
• 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: 5 KG
• Date Report Sent to FDA: 12/01/2022