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

Model Number	92431
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fda mw report mw5169668 reported, patient uses the ballard 8 fr suction catheters, which were recently recalled for being non-sterile.In the last week, patient experienced symptoms of pneumonia.Caregivers believe this could have been caused by the use of the non-sterile suction catheters.The symptoms have since subsided.Upon further investigation, the patient had the recalled product in the home.
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.All information reasonably known as of 10 jun 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: h8; h10 additional information-investigation completion: d4; h2; h6.H6: (appropriate term/code not available): c & d- lot number 1555215 was confirmed to have been shipped directly to the distribution center prior to sterilization.The product involved in the report was not returned for evaluation, additionally no photographic or videographic evidence was provided; however, the complaint is confirmed.Reported lot number 1555215 was confirmed to have been shipped directly to the airlife el paso distribution center prior to sterilization.A capa has been created to document the investigation and all related action plan(s).Complaints will continue to be monitored for possible trends.All information reasonably known as of 17 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 complaint (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
Fda mw report mw5169668 reported, patient uses the ballard 8 fr suction catheters, which were recently recalled for being non-sterile.In the last week, patient experienced symptoms of pneumonia.Caregivers believe this could have been caused by the use of the non-sterile suction catheters.The symptoms have since subsided.Upon further investigation, the patient had the recalled product in the home.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM
• Common Device Name: BALLARD CLOSED SUCTION CATHETER, ELBOW, 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 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22176120
• Report Number: 8030647-2025-00055
• Device Sequence Number: 9520372
• Product Code: BSY
• UDI-Device Identifier: 00609038924311
• UDI-Public: (01)00609038924311(10)1555215(11)241205(17)291124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 92431
• Device Catalogue Number: 20083
• Device Lot Number: 1555215
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown