MAUDE Adverse Event Report: AVANOS MEDICAL INC AVANOS; MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL,

Model Number	35116
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: the leak has been found in several freshly opened tubes.There was no reported injury.There was three different patients affected by this issue; therefore 3 different reports will be submitted.The 1st rreport number is 3011270181-2025- 20008, and the 2nd report is 3011270181-2025-20009.
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 (b)(6) 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 leak has been found in several freshly opened tubes.There was no reported injury.There was three different patients affected by this issue; therefore, 3 different reports will be submitted.The 1st rreport number is 3011270181-2025- 20008, and the 2nd report is 3011270181-2025-20009.
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 (b)(6) 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 device history record review vendor notified of the incident.Lot code provided by distributor indicated to be cm3300003.Sku noted to be 35116.30 sep 2025 - complainant name updated.1 oct 2025 - complainant states that a total of 3 devices failed from the same pn/ln combination (info updated).Complainant confirms this is a duplicate complaint (see (b)(4).Vendor completed investigation (2 oct 2025) and concluded: at the time of the investigation a sample was not available for evaluation.No deviations or non-conformances were noted in the dhr.No main lumen leak issues were observed since a process validation was performed in 2017 at the location.Expansion mandrels were inspected and determined to be conforming and not deformed/defective in any way such that a lumen break could be created.Operators were retrained as a preventative measure, however no root cause could be identified.

• Brand Name: AVANOS
• Common Device Name: MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL,
• Manufacturer (Section D): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23103387
• Report Number: 3011270181-2025-20011
• Device Sequence Number: 9847911
• Product Code: BTR
• UDI-Device Identifier: 00609038351162
• UDI-Public: (01)00609038351162(10)CM3300003
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 35116
• Device Catalogue Number: 35116
• Device Lot Number: CM3300003
• 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: 02/20/2026
• 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