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

Model Number	98383
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.The udi-pi is not available as no product number was provided.All information reasonably known as of 29 oct 2025 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.
Event or Problem Description
Event description (fda b5): sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 8030647-2025-00113 for the second report it was reported: the inline suction device could not pass through the opening of the connector, discovered during use on a ventilated infant.There was no reported injury.
Additional Manufacturer Narrative
Additional information-investigation completion: d4; h2; h6 the product involved in the report has not been returned for evaluation, additionally no photographic or videographic evidence was provided; therefore the complaint could not be confirmed.However, this is a known failure mode, the possible root cause was determined to be material segregated incorrectly.Operator retraining performed which included performing visual inspection every hour.The device history record for lot 30327230 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 dec 2025 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.
Event or Problem Description
Event description (fda b5): sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 8030647-2025-00113 for the second report.It was reported: the inline suction device could not pass through the opening of the connector, discovered during use on a ventilated infant.There was no reported injury.

• Brand Name: AVANOS MEDICAL
• Common Device Name: BALLARD CLOSED SUCTION CATHETER SYSTEM FOR NEONATES/PEDIATRICS, Y-ADAPTER
• 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: 23420516
• Report Number: 8030647-2025-00112
• Device Sequence Number: 8178882
• Product Code: BSY
• UDI-Device Identifier: 10609038983834
• UDI-Public: (01)10609038983834(10)30327230(17)290602(11)240612
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 98383
• Device Catalogue Number: 195-5
• Device Lot Number: 30327230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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