MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13222
Medical Device Problem Code	Decrease in Pressure (1490)
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.The device history record for lot aa8281v01 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 nov 2019 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.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
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving the same patient.This is the first of three reports.Refer to 9611594-2019-00238 for the second report.Refer to 9611594-2019-00239 for the third report.It was reported that during the emergency resuscitation of a patient in the emergency room, the tube was found to have a cuff leak.There was no harm to the patient, as ventilation was successful throughout.Additional information has been requested but not yet received.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9349290
• Report Number: 9611594-2019-00237
• Device Sequence Number: 13517578
• Product Code: BTR
• UDI-Device Identifier: 30680651132223
• UDI-Public: 30680651132223
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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 Expiration Date: 10/01/2020
• Device Model Number: 13222
• Device Catalogue Number: N/A
• Device Lot Number: AA8281V01
• 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: 10/28/2019
• Initial Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1