MAUDE Adverse Event Report: AVANOS MEDICAL INC MICROCUFF* ENDOTRACHEAL TUBE FOR ADULTS

Model Number	35216
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported leak in the cuff, discovered during patient use (multiple occurrences).The ett tube was replaced.There was no reported injury.Reportable-while no harm or injury was reported, any component that is part of the vent circuit (flex connector, double swivel elbow, y-adapter, t-piece, ett adapter, etc.) breaks, cracks, or leaks after the vent circuit has been established on the patient and which requires a replacement ett could cause or lead to a serious injury and/or harm.
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 29 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.The complaint of "leak in the cuff" regarding parts 35215 and 35216 were not confirmed.The root cause was determined to be raw material issues.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been 0 other complaints regarding the same parts and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
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 29 aug 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported leak in the cuff, discovered during patient use (multiple occurrences).The ett tube was replaced.There was no reported injury.Reportable-while no harm or injury was reported, any component that is part of the vent circuit (flex connector, double swivel elbow, y-adapter, t-piece, ett adapter, etc.) breaks, cracks, or leaks after the vent circuit has been established on the patient and which requires a replacement ett could cause or lead to a serious injury and/or harm.

• Common Device Name: MICROCUFF* ENDOTRACHEAL TUBE FOR ADULTS
• 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, mexico 84160 ; MX 84160
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22929346
• Report Number: 8030647-2025-00079
• Device Sequence Number: 10294350
• Product Code: BTR
• UDI-Device Identifier: 00609038352169
• UDI-Public: (01)00609038352169
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: 35216
• Device Catalogue Number: 35216
• Device Lot Number: UNKNOWN
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown