MAUDE Adverse Event Report: AVANOS MEDICAL, INC. BALLARD* CLOSED SUCTION SYSTEM FOR ADULTS; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	93905
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Connected new ballard to patient's trach (switched from a smaller size); 1 hour later, attempted to suction patient and no secretions able to be suctioned.Checked suction tubing which was working.Attempted to suction again unsuccessfully.Disconnected ballard from patient and noticed not able to suction.Changed to a new ballard again and successfully suctioned the patient.

• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 21651106
• Report Number: 21651106
• Device Sequence Number: 15780111
• Product Code: BSY
• UDI-Device Identifier: 00609038939056
• UDI-Public: (01)00609038939056
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2025
• Report Date (Section F): 03/18/2025

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: Other
• Device Model Number: 93905
• Device Catalogue Number: 2160
• Device Lot Number: 30240008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• 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: Unknown
• Date Report Sent to FDA: 03/18/2025