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

Model Number	35215
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
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 13 nov 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: the pilot balloons are bursting, and the patient is losing volume while on a vent.
Event or Problem Description
It was reported: the pilot balloons are bursting, and the patient is losing volume while on a vent.
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 13 nov 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 "the pilot balloons are bursting, and the patient is losing volume while on a vent" regarding parts 35215 and 35216 were not confirmed.The root cause was not able to be determined.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 4 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.Risk assessment: the ultimate risk is low, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/ caregiver: performed risk assessment with (b)(4).The complaint most closely aligns with risk id (b)(4) with a potential cause of hazard being "cuff having pin hole".Severity = 6, likelihood of occurrence = 2, calculated occurrence = 0.013%.Per (b)(4), these levels indicate low risk.2.Regulatory/ compliance: reviewed (b)(4), and there is low regulatory/ compliance risk.3.Brand recognition and customer impact: reviewed (b)(4), and there is low brand recognition/customer impact.

• Common Device Name: MICROCUFF* ADULT ENDOTRACHEAL TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, mexico ; MX
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23550861
• Report Number: 8030647-2025-00129
• Device Sequence Number: 13191528
• Product Code: BTR
• UDI-Device Identifier: 00609038352152
• UDI-Public: (01)00609038352152(10)CM5009001
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 35215
• Device Catalogue Number: 35215
• Device Lot Number: CM5009001
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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