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

Model Number	93824
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patients.This is the first of two reports.Refer to 8030647-2025-00003 for the second report it was reported, an attempt to reposition the neonate on the oscillator vent was made; the baby received slight condensation through the endotracheal tube (ett) and their heart rate and oxygen saturations began to drop.An attempt to suction the neonate with the current 6french ett suction and the ballard was made; however, the catheter kept popping off of the y piece (would not pass the y interface), which resulted in circuit pressure loss.An unsuccessful attempt to twist the catheter internally was performed; the catheter was replaced.
Additional Manufacturer Narrative
The actual complaint product was not available to be returned for evaluation.A review of the device history record is in progress.4581- appropriate term/code not available- decreased heart rate.All information reasonably known as of 03 jan 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.
Additional Manufacturer Narrative
Correction: g1.Additional information: d4; h64581- appropriate term/code not available- decreased heart rate.Photographic /video evidence, provided by the reporter, was reviewed and confirmed the event as reported.The actual complaint product was not available for return; however, as this is a known device problem evaluation of the device was not necessary.The root cause is traced to the manufacturing process; measures are in place to prevent the issue from reoccurring.The device history record for lot 30327327 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 may 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 two different incidences, which were associated with separate units, involving the same patients.This is the first of two reports.Refer to 8030647-2025-00003 for the second report.It was reported, an attempt to reposition the neonate on the oscillator vent was made; the baby received slight condensation through the endotracheal tube (ett) and their heart rate and oxygen saturations began to drop.An attempt to suction the neonate with the current 6french ett suction and the ballard was made; however, the catheter kept popping off of the y piece (would not pass the y interface), which resulted in circuit pressure loss.An unsuccessful attempt to twist the catheter internally was performed; the catheter was replaced.

• 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, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 northridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 21067907
• Report Number: 8030647-2025-00002
• Device Sequence Number: 16138402
• Product Code: BSY
• UDI-Device Identifier: 00609038938240
• UDI-Public: (01)00609038938240(10)30327327(17)290520(11)240521)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 93824
• Device Catalogue Number: 196
• Device Lot Number: 30327327
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Female