MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM; BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC

Model Number	98384
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the new in-line suction catheter (csc) was attached to the endotracheal tube (ett).It was noted that upon the second use of the csc it had filled with air, the ventilator alarmed high leak, and the patient desaturated.The port was turned on and off, the csc was removed and the device was replaced.There was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; additionally, no photographic /video evidence was provided.Without photographic /video evidence the complaint could not be confirmed; without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 30327760 was reviewed and the product was produced according to product specifications.All information reasonably known as of 17 mar 2026 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.The fda initial report for mw report mw 8030647-2025-00047 was submitted on 24apr2025 and the following ack2 was received confirming asuccessful esg submission: submission ci250424193054.Ac33f7c6ccae4b8bbbae0b8091111199 has been successfully transmitted to cdrh core id: ci250424193054.Ac33f7c6ccae4b8bbbae0b8091111199,.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM
• Common Device Name: BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC
• 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, 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 24645111
• Report Number: 8030647-2025-00047
• Device Sequence Number: 10207355
• Product Code: BSY
• UDI-Device Identifier: 00609038983844
• UDI-Public: (01)00609038983844(10)30327760(17)290523(11)240524
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

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: Health Professional
• Device Model Number: 98384
• Device Catalogue Number: 196-5
• Device Lot Number: 30327760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown