MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS; MICROCUFF ET TUBE PED MAGILL,6.5MM,10

Model Number	35118
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report is not available to be 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 06 mar 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
Sunmed holdings llc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the first of four reports.Refer to 3011270181-2026-20002 for the second report.Refer to 3011270181-2026-20003 for the third report.Refer to 3011270181-2026-20004 for the fourth report.It was reported, the ballon did not remain inflated and the patient had to be reintubated.There was no report of harm or injury as a result of this reported event.

• Brand Name: AVANOS
• Common Device Name: MICROCUFF ET TUBE PED MAGILL,6.5MM,10
• 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: 24539481
• Report Number: 3011270181-2026-20001
• Device Sequence Number: 21100088
• Product Code: BTR
• UDI-Device Identifier: 00609038351186
• UDI-Public: (01)00609038351186
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/06/2026

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: 35118
• Device Catalogue Number: 35118
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• 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