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

Model Number	35115
Medical Device Problem Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
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 14 march 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
Respiratory control was fine prior and during surgery.After returning to the room, the patient's ventilation rate did not increase, and although bag ventilation was performed manually,the airflow was not going well.Therefore extubated the patient.The micro cuff was found to be kinked at 8 cm from the tip.This was the first time this had happened, as the micro cuff usually does not remain bent during intraoperative x-rays.At the time of recovery of the product in question, the mark of the bent portion could not be confirmed by the naked eye.
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 14 march 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.Complaint was considered not confirmed based on customer narrative of events and images provided.A 24 month review was conducted and no additional complaints were identified related to this issue, therefore no trend was observed.The lot number was provided not; the vendor was notified of the incident.This incident was not identified as an increasing trend.No further action to be taken.
Event or Problem Description
Respiratory control was fine prior and during surgery.After returning to the room, the patient's ventilation rate did not increase, and although bag ventilation was performed manually,the airflow was not going well.Therefore extubated the patient.The micro cuff was found to be kinked at 8 cm from the tip.This was the first time this had happened, as the micro cuff usually does not remain bent during intraoperative x-rays.At the time of recovery of the product in question, the mark of the bent portion could not be confirmed by the naked eye.

• 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: 21612809
• Report Number: 3011270181-2025-02001
• Device Sequence Number: 7662665
• Product Code: BTR
• UDI-Device Identifier: 00609038351155
• UDI-Public: (01)00609038351155
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 35115
• Device Catalogue Number: 35115
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown