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

Model Number	35113
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 22 apr 2025 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 (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the patient was intubated with the microcuff 4.0 tube; however, the staff were not able to suction them properly which resulted in a delay in care.A work around was developed, using a different endotracheal tube (ett) hub adapter.There was no reported injury.Additional information received 11apr2025 reported, due to a backorder with their normal endotracheal tube, the staff used the y-style neo/pediatric suction elbow style catheters with the microcuff and noticed the catheter could not advance past the adapter that connects it to the suction catheter.The walls on the adapter seemed 'thicker' and the catheter frequently hung-up and kinked when the clinicians tried to advance it.There was no reported injury.

• Brand Name: AVANOS MEDICAL, INC
• Common Device Name: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGIL
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta, ga 30004 ; MX 30004
• Manufacturer (Section G): COMMAND MEDICAL NICARAGUA SA; km 12.5 carretera norte; parque industrial las mercedes; edificio 16, managua ; NU
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids
• MDR Report Key: 22146898
• Report Number: 3011270181-2025-20002
• Device Sequence Number: 15540615
• Product Code: BTR
• UDI-Device Identifier: 00609038351131
• UDI-Public: (01)00609038351131(10)CM4116001
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 35113
• Device Catalogue Number: 35113
• Device Lot Number: CM4116001
• 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: 03/24/2025
• Initial Report FDA Received Date: 06/04/2025
• 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
• Patient Sex: Unknown