MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM; BALLARD CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW

Model Number	99409
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 07 nov 2024 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical complaint database and identified as complaint comp (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 avanos medical inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the patient felt uncomfortable and when the nurse went to check on them, they found the flapper valve was in the flex connector.[the device was] immediately replaced and treated; there was no injury.
Event or Problem Description
It was reported, the patient felt uncomfortable and when the nurse went to check on them, they found the flapper valve was in the flex connector.[the device was] immediately replaced and treated; there was no injury.
Additional Manufacturer Narrative
Correction: d3; g1.Investigation conclusion: d4; h2; h6.The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed: the flapper valve and detached piece were examined under magnification.The remaining portion of the flapper valve, inside the manifold, had the correlating segments of the prongs.The detached flap was severed at the two prongs.It was additionally noted, the surface of the flap had a cracked appearance on both sides.The reported event could be confirmed as reported.The failure mode is under review.The device history record for lot 30330340 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 aug 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)_avanos legacy 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.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM
• Common Device Name: BALLARD CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW
• 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 30004 ; 4704485487
• MDR Report Key: 20746709
• Report Number: 8030647-2024-00079
• Device Sequence Number: 12852680
• Product Code: BSY
• UDI-Device Identifier: 00609038994093
• UDI-Public: (01)00609038994093(10)30330340(11)240620(17)290610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 99409
• Device Catalogue Number: 22703-4J
• Device Lot Number: 30330340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: Required Intervention; Other
• Patient Sex: Female