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

Model Number	35116
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.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 21 may 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 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, after completion of the procedure, during extubation of the patient the endotracheal tube (ett) kinked and they were unable to the suction patient.To resolve the issue, the respiratory therapist (rt) put their finger down the back of the patient's throat to straighten out the kink; however, as soon as she removed her finger, it immediately bent again.There was no report of serious harm or injury as a result of this reported event.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.The root cause was determined to be caused by an ovality condition formed during the extrusion process.A process improvement was implemented in (b)(6) 2025 to the extruder tooling to provide greater internal air support within the tube.This increased internal pressure and improved wall stability.Additionally, the position of the extrusion die relative to the extrusion pin was adjusted, under typical extrusion conditions, the die and pin had been set flush; however, evaluation indicated that this configuration contributed to tube ovality.By retracting the pin approximately 1/16 inch from the face of the die improved tube roundness and reduced the likelihood of reoccurrence.We will continue to monitor for 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 (b)(6) 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 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, after completion of the procedure, during extubation of the patient the endotracheal tube (ett) kinked and they were unable to the suction patient.To resolve the issue, the respiratory therapist (rt) put their finger down the back of the patient's throat to straighten out the kink; however, as soon as she removed her finger, it immediately bent again.There was no report of serious harm or injury as a result of this reported event.

• 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: 25250181
• Report Number: 3011270181-2026-20006
• Device Sequence Number: 16088887
• Product Code: BTR
• UDI-Device Identifier: 00609038351162
• UDI-Public: (01)00609038351162
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: 35116
• Device Catalogue Number: 35116
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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