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

Model Number	99426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported; the detached flapper valve was found in the patient's throat 2 days after use.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 19 dec 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 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
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 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
It was reported, the flapper valve fell on the first day of use on the patient; it is unclear where the flapper valve was found; however, it was not found in the patient's airway.There was no reported injury.
Additional Manufacturer Narrative
Correction: e1; g1.Investigation conclusion: d4; h2; h6.The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the device was received with the flapper valve detached.When viewed under magnification the detached portion of the flapper valve exhibited a crackled surface texture on both sides.Additionally, the flapper valve ring (inside the dse) exhibited the same crackled appearance.The break occurred in the two prongs between the ring and the flap.The reported event could be confirmed as reported; however, the root cause is undetermined.The device history record for lot 30327334 was reviewed and the product was produced according to product specifications.All information reasonably known as of 04 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 (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
It was reported, the flapper valve fell on the first day of use on the patient; it is unclear where the flapper valve was found; however, it was not found in the patient's airway.There was no reported injury.
Additional Manufacturer Narrative
Correction: b4; e1; g1.Investigation conclusion: d4; h2; h6.The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the device was received with the flapper valve detached.When viewed under magnification the detached portion of the flapper valve exhibited a crackled surface texture on both sides.Additionally, the flapper valve ring (inside the dse) exhibited the same crackled appearance.The break occurred in the two prongs between the ring and the flap.The reported event could be confirmed as reported; however, the root cause is undetermined.The device history record for lot 30327334 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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
It was reported, the flapper valve fell on the first day of use on the patient; it is unclear where the flapper valve was found; however, it was not found in the patient's airway.There was no reported 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, 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 northridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20984330
• Report Number: 8030647-2024-00092
• Device Sequence Number: 7788116
• Product Code: BSY
• UDI-Device Identifier: 00609038994260
• UDI-Public: (01)00609038994260(10)30327334(240)109942603(17)290602(11)240605
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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: 99426
• Device Catalogue Number: 2271603-4J
• Device Lot Number: 30327334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 01/30/2025; 07/02/2025; 08/09/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 02/03/2025; 08/04/2025; 08/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Female
• Patient Weight: 52 KG