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

Model Number	93906
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Inline suction ballard had a hole with a small leak.Found when turning patient's head to right.Ballard was quickly changed to new ballard safely.No pt harm was reported.Similar issue was reported for another patient as well.This specific lot was sequestered and taken out of use.

• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 24625919
• Report Number: 24625919
• Device Sequence Number: 9173804
• Product Code: BSY
• UDI-Device Identifier: 00609038939063
• UDI-Public: (01)00609038939063
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026
• Report Date (Section F): 02/18/2026

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
• Device Model Number: 93906
• Device Catalogue Number: 2205
• Device Lot Number: 1651470
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Date Report Sent to FDA: 02/18/2026