MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS; BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal

Model Number	197
Medical Device Problem Codes	Gas/Air Leak (2946); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/13/2026
Type of Reportable Event	Malfunction

• Brand Name: AVANOS
• Common Device Name: BALLARD CLOSED SUCTION SYSTEM FOR NEONATES/PEDIATRICS, Y-Adapter, Endotracheal
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S de RL de CV; carretera internacional; salida norte no. 1053; magdalena, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 25849491
• Report Number: 8030647-2026-00051
• Device Sequence Number: 16047836
• Product Code: BSY
• UDI-Device Identifier: 20889483563691
• UDI-Public: (01)20889483563691(10)1561171
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 197
• Device Catalogue Number: 197
• Device Lot Number: 1561171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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