MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-7.3-5.5-16; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35116
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 18 oct 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
It was reported in the journal article "cuff leakage caused by automatic cuff pressure monitor and water condensation in the inflation tube of microcuff endotracheal tube" that there was an occurrence of ventilation failure on a patient two days after patient admission.The patient had been admitted in the intensive care unit and intubated with 5.5 mm id microcuff endotracheal tube.Intracuff pressure was set at 15 cmh2o and monitored by a continuous automatic cuff pressure monitor.The failure was found to be caused by water condensation in the inflation tube.When the intracuff pressure was increased to from 15 to 25cm h2o, water in the inflation tube moved to the cuff and the issue resolved.There was no injury to the patient.

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9224575
• Report Number: 3011270181-2019-00061
• Device Sequence Number: 10799481
• Product Code: BTR
• UDI-Device Identifier: 10680651351163
• UDI-Public: 10680651351163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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: 35116
• Device Catalogue Number: 103511603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 20