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

Model Number	35218
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 19 sept 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 21 cfr 803, 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 cuff "blew" post intubation on multiple (five (5)) patients, across three (3) units and in the emergency room (er) in less than a two-month period.All the patients were re-intubated without incident.5 different reports will be submitted for each patient.Report #'s: 8030647-2025-00082, 8030647-2025-00084, 8030647-2025-00085, and 8030647-2025-00086.
Event or Problem Description
It was reported: the cuff "blew" post intubation on multiple (five (5)) patients, across three (3) units and in the emergency room (er) in less than a two-month period.All the patients were re-intubated without incident.5 different reports will be submitted for each patient.1st report 8030647-2025-00082, 3rd 8030647-2025-00084, 4th 8030647-2025-00085, 5th 8030647-2025-00086.
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 sept 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 (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.Complaint was considered not confirmed based on lack of sample availability or images of the "exploded" cuff.A 24 month review was conducted and 1 additional complaint was identified as related to this issue.3 lot numbers were provided, the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.Risk assessment 1.Patient/caregiver risk dhfe-08605 microcuff ett dfmea rev 07 was reviewed to perform a risk assessment.Hazard id d 4.6 was identified as most aligned with this incident.The hazard reads "cuff burst" with an associated severity rating of 4/5 - severe.The expected occurrence for this failure mode rates as a 1-improbable.Per table 1 in sop-20006-c1, a severity of 4 and an occurrence level of "improbable" results in a "low" risk and dictates that a capa is optional.Lsit-harm noted to be 2-remote.This incident represents a "medium" patient risk.From the information reported, it requires supplier investigation to determine a potential root cause to the incident.2.Compliance/regulatory risk per regulatory risks listed in tables 2 and 2a of ref-20001-c1, the risk is determined to be "low".

• 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 84160 ; MX 84160
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI
• MDR Report Key: 23104217
• Report Number: 8030647-2025-00083
• Device Sequence Number: 9151290
• Product Code: BTR
• UDI-Device Identifier: 00609038352183
• UDI-Public: (01)00609038352183(10)100104216
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/19/2025

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: 35218
• Device Catalogue Number: 35218
• Device Lot Number: 100104216
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/20/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 35215 MICROCUFF* ADULT ENDOTRACHEAL TUBE; 35215 MICROCUFF* ADULT ENDOTRACHEAL TUBE; 35216 MICROCUFF* ADULT ENDOTRACHEAL TUBE; 35216 MICROCUFF* ADULT ENDOTRACHEAL TUBE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown