MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS, VAP MICROCUFF ENDOTRACHEAL TUBES; MICROCUFF ADULT ENDOTRACHEAL TUBE

Model Number	35215
Medical Device Problem Codes	Material Twisted/Bent (2981); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 3011270181-2024-00128 for the first report.Refer to 3011270181-2024-00129 for the second report.It was reported, the tube kinked in the patient¿s airway/trachea, which was discovered when they were unable to pass the inline suction catheter during bronchoscopy and unable to perform routine suctioning.It was additionally reported; the patient underwent unsuccessful emergency bronchoscopies to try to fix the kink; there was no reported injury.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation; without a sample to perform functional evaluation a root cause cannot be determined.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 for the alleged device.All information reasonably known as of (b)(6) 2024 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical 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 avanos medical inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The actual complaint product was not available for return; however, the reporter provided photograph(s) of the alleged device.The image(s) provided were reviewed and the reported issue of, kinked tube was confirmed.However, without a sample to perform functional evaluation a root cause cannot be determined.Based on the stock code, no deviation was found during the revision of the manufacturing process.All information reasonably known as of 08 jan 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 avanos medical inc.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 avanos medical inc.Avanos medical inc.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 avanos medical 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 avanos medical inc.Product is defective or caused serious injury.

• Brand Name: AVANOS, VAP MICROCUFF ENDOTRACHEAL TUBES
• Common Device Name: MICROCUFF ADULT ENDOTRACHEAL TUBE
• 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, managua
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20844899
• Report Number: 3011270181-2024-00130
• Device Sequence Number: 17083194
• Product Code: BTR
• UDI-Device Identifier: 00609038352152
• UDI-Public: (01)00609038352152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• 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,Followup
• Report Date (Section B): 01/09/2025

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: 35215
• Device Catalogue Number: 35215
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• 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: Unknown