MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.5 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13221
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, aa7170v01, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of 04-apr-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, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical, inc.Received a single report that referenced ten different incidences, which were associated with separate units, involving ten different events.This is the eighth of ten reports.Refer to 9611594-2019-00066 for the first event.Refer to 9611594-2019-00067 for the second event.Refer to 9611594-2019-00068 for the third event.Refer to 9611594-2019-00069 for the fourth event.Refer to 9611594-2019-00070 for the fifth event.Refer to 9611594-2019-00071 for the sixth event.Refer to 9611594-2019-00072 for the seventh event.Refer to 9611594-2019-00074 for the ninth event.Refer to 9611594-2019-00075 for the tenth event.It was reported the endotracheal tube blue connector was coming off easily from the tube, creating a disconnection issue and this disconnection also occurs when the temperature rises in the respiratory circuit.This impacts the ventilator patients who are on ventilator high pressure mode.There was no reported patient injury.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.5 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8488404
• Report Number: 9611594-2019-00073
• Device Sequence Number: 1871352
• Product Code: BTR
• UDI-Device Identifier: 30680651132216
• UDI-Public: 30680651132216
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 06/01/2019
• Device Model Number: 13221
• Device Catalogue Number: 101322100
• Device Lot Number: AA7170V01
• 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: 03/15/2019
• Initial Report FDA Received Date: 04/05/2019
• Patient Sequence Number: 1