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

Model Number	35216
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was noted to have acute desaturation.Et tube noted to be at 20 cm.

• 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: 10118332
• Report Number: 10118332
• Device Sequence Number: 14053563
• Product Code: BTR
• UDI-Device Identifier: 10680651352160
• UDI-Public: (01)10680651352160
• 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): 06/01/2020
• Report Date (Section F): 06/01/2020

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: No Information
• Device Model Number: 35216
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60
• Date Report Sent to FDA: 06/01/2020