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

Model Number	196
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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: 50940510
• Report Number: 8030647-2026-00070
• Device Sequence Number: 9734710
• Product Code: BSY
• UDI-Device Identifier: 00609038938240
• UDI-Public: (01)00609038938240
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 196
• Device Catalogue Number: 196
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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