MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE; 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	04/29/2019
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 20 may 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the "ett [endotracheal tube] connector popped off from patient with rt [respiratory therapist] in room luckily.No adverse effects noted or documented.However they did try going to a larger size adapter from another tube and it would not work.The intensivist found some super glue somewhere and applied it.The tube is still functioning with the glue." no patient injury reported.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8627115
• Report Number: 9611594-2019-00099
• Device Sequence Number: 2169047
• Product Code: BTR
• UDI-Device Identifier: 10680651132212
• UDI-Public: 10680651132212
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

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: 13221
• Device Catalogue Number: 101322100
• 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: 04/30/2019
• Initial Report FDA Received Date: 05/21/2019
• Patient Sequence Number: 1
• Patient Age: 25 YR