MAUDE Adverse Event Report: Avanos Medical Inc Ballard; Closed Suction System for Neonates / Pediatrics

Model Number	208
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction

• Brand Name: Ballard
• Common Device Name: Closed Suction System for Neonates / Pediatrics
• 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, mexico 84160 ; MX 84160
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; +1(616)259-8415
• MDR Report Key: 25864644
• Report Number: 8030647-2026-00052
• Device Sequence Number: 18800691
• Product Code: BSY
• UDI-Device Identifier: 00609038938332
• UDI-Public: (01)00609038938332(10)1667709
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2026

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: 208
• Device Catalogue Number: 208
• Device Lot Number: 1667709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown