MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-8.7-6.5-20; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35118
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Oxygen Saturation (2477); Respiratory Arrest (4461)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
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 events.This is the first of three reports.Refer to 3011270181-2021-00059 for the second event.Refer to 3011270181-2021-00060 for the third event.It was reported there was difficulty suctioning the patient and passing the suction catheter through the microcuff endotracheal tube (ett).The patient was intubated with the microcuff endotracheal tube (ett) on the morning of (b)(6) 2021.On (b)(6) 2021 at 1715 the patient became bradycardic with a heart rate in the 60¿s heart beats per minute.The patient's heart rate "dropped to the 30¿s" with loss of pulses and oxygen desaturations.A code blue alert was called and chest compressions were started.The patient was extubated and the microcuff tube was replaced.The patient improved with ventilation.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 16-dec-2021 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, inc.Complaint database and identified as complaint (b)(4).

• Brand Name: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-8.7-6.5-20
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• 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; managua, managua ; NU
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13021379
• Report Number: 3011270181-2021-00058
• Device Sequence Number: 4650091
• Product Code: BTR
• UDI-Device Identifier: 00609038351186
• UDI-Public: 00609038351186
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35118
• Device Catalogue Number: N/A
• 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: 11/18/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 80 KG