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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
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 not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 10 apr 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
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 8030647-2025-00041 for the first report.Refer to 8030647-2025-00042 for the second report.It was reported, the closed inline suction system for ventilated babies inflated after suctioning which caused the ventilator to alarm for high patient leak (up to 100%) with a displayed tidal volume of zero.The patient required high fraction of inspired oxygen (fio2) and intermittent positive pressure ventilation (ippv) via the neo puff in order to achieve effective ventilation.The device was disconnected/reconnected and reinflated and the patient's peripheral capillary oxygen saturation (spo2) dropped.The inline suction was replaced and the issue resolved.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 8030647-2025-00041 for the first report.Refer to 8030647-2025-00042 for the second report.It was reported, the closed inline suction system for ventilated babies inflated after suctioning which caused the ventilator to alarm for high patient leak (up to 100%) with a displayed tidal volume of zero.The patient required high fraction of inspired oxygen (fio2) and intermittent positive pressure ventilation (ippv) via the neo puff in order to achieve effective ventilation.The device was disconnected/reconnected and reinflated and the patient's peripheral capillary oxygen saturation (spo2) dropped.The inline suction was replaced and the issue resolved.
Additional Manufacturer Narrative
Correction: d4.Additional information-investigation conclusion: d4; h4; h6.The actual complaint product was not returned for evaluation; additionally no photographic or videographic evidence was provided.The complaint was not confirmed and the 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 24 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.

• 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 ; MX 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: 21819182
• Report Number: 8030647-2025-00043
• Device Sequence Number: 8742720
• Product Code: BSY
• UDI-Device Identifier: 00609038983844
• UDI-Public: (01)00609038983844(10)30327760(11)240604(17)290523
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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