MAUDE Adverse Event Report: Avanos Medical Inc. AVANOS; MICROCUFF Pediatric Endotracheal Tube, Oral/Nasal Magill

Model Number	35114
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.Analysis of the photos and distributor investigation provided confirmed the reported complaint.The root cause was not determined.A review of complaint history identified no additional complaints involving the same part number and a similar failure mode within the preceding 24 months.No additional trends were identified; monitoring will continue for any emerging trends a review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 16 september 2026 has been included in this 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 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 an airlife product is defective or caused serious injury.
Event or Problem Description
It was reported that during a dental procedure, the physician observed that the inflation tube had separated from the body of the endotracheal tube.A scratch was noted approximately 2 mm from the separation point.There was no reported harm or injury associated with this event.

• Brand Name: AVANOS
• Common Device Name: MICROCUFF Pediatric Endotracheal Tube, Oral/Nasal Magill
• Manufacturer (Section D): Avanos Medical Inc.; 5405 winward parkway; alpharetta GA 30004
• Manufacturer (Section G): Avanos Medical Inc.; 5405 winward parkway; alpharetta, ga 30004 ; MX 30004
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 50058278
• Report Number: 8030647-2026-00055
• Device Sequence Number: 15733247
• Product Code: BTR
• UDI-Device Identifier: 00609038351148
• UDI-Public: (01)00609038351148
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 35114
• Device Catalogue Number: 35114
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown