MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35216
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Respiratory therapy reports problems with the avanos microcuff endotracheal tubes, in adult sizes 6.0mm, 7.5mm, and 8.0mm.The 15mm connector, where the ventilator or o2 source connects, disconnects from the neck of the ett.The 15mm connector appears to become loose from the neck of the ett when warmed in the airway.When this occurs, the patient is not effectively being ventilated.At least one patient has had to be re-intubated in order to continue ventilator treatment.Overnight on [redacted date], there was a patient in the medical icu who coded post intubation.While taking the colormetric off and placing the emma, the blue piece just popped off.The respiratory therapist was able to get the connector back on quickly.

• Brand Name: MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18408532
• Report Number: 18408532
• Device Sequence Number: 19505743
• Product Code: BTR
• UDI-Device Identifier: 00609038352169
• UDI-Public: (01)00609038352169(240)103521605(17)280428(10)CM3118001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023
• Report Date (Section F): 11/28/2023

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
• Device Model Number: 35216
• Device Catalogue Number: 35216
• Device Lot Number: CM3118001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/28/2023