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

Model Number	35112
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation 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 05 jun 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, called into patient's room due to registered nurse (rn) bagging patient.Rn mentioned a leak in the endotracheal tube (ett), respiratory therapist (rt) checked tube placement, and it was a little high where it was supposed to be placed.Both rt and other rt retaped the tube to the correct position which was 9 at the gum and a chest xray (cxr) was taken for tube placement.Upon x-ray the tube was high and confirmed by advanced practice nurse (apn).The tube was then pushed in to 10 and another x-ray was taken.Upon x-ray the tube was still high which was confirmed by apn and so the tube was once again pushed to 11.The x-ray still showed it was high.The patient's saturations were lower, so the attending medical doctor (md) and other apn was called to the room to review x-rays as well.Md asked for the clinical medical assistant certified (cmac) to use to observe what was going on with the ett inside the patient's mouth.Once the blade was in use, the camera showed the ett was through the vocal cords showing the ett was still in place, but due to the patient desatsurations and brady, the decision was made to switch out the tubes just in case there was something defective with the tube.

• 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,managua, ni ; NU
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22155518
• Report Number: 3011270181-2025-20003
• Device Sequence Number: 8842178
• Product Code: BTR
• UDI-Device Identifier: 10609038351121
• UDI-Public: (01)10609038351121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35112
• Device Catalogue Number: 35112
• Device Lot Number: UNKNOWN
• 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: 05/06/2025
• Initial Report FDA Received Date: 06/05/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female