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

Model Number	35113
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction

• Brand Name: AVANOS
• 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): Avanos Medical Inc; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; +1(616)259-8415
• MDR Report Key: 50011352
• Report Number: 8030647-2026-00054
• Device Sequence Number: 8412058
• Product Code: BTR
• UDI-Device Identifier: 00609038351155
• UDI-Public: (01)00609038351155(10)CM5086002
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 35113
• Device Catalogue Number: 35113
• Device Lot Number: CM4197001, CM5086002
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/19/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown