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

Model Number	35115
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: (appropriate term/code not available): code e- occluded the airway which prevented the suction catheter from being passed the product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 16 jan 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3011270181-2026-00002 for the second report.Refer to 3011270181-2026-00003 for the third report.It was reported, the tube twisted after insertion and occluded the airway which prevented the suction catheter from being passed; the catheter was replaced.There was no reported injury.

• Brand Name: AVANOS MEDICAL, INC.
• 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): COMMAND MEDICAL NICARAGUA SA; km 12.5 carretera norte; parque industrial las mercedes; edificio 16, ni ; NU
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 24101310
• Report Number: 3011270181-2026-00004
• Device Sequence Number: 10312530
• Product Code: BTR
• UDI-Device Identifier: 00609038351155
• UDI-Public: (01)00609038351155(10)CM3291003(17)281018(11)231018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 35115
• Device Catalogue Number: 35115
• Device Lot Number: CM3291003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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