MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13221
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda medwatch / fda user facility report #mw5094284 is included as an attachment.The device history record for lot aa9070v01 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 28 may 2020 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 inc.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 9611594-2020-00087 for the second report.Refer to 9611594-2020-00088 for the third report.Fda medwatch / fda user facility report #mw5094284 was received on 07-may-2020.The following information was provided: "patient was intubated using a 7.5 hilo vac endotracheal tube, once intubated, the cuff of the endotracheal tube would not inflate.Had to extubate and re intubate already hypoxic patient." additional information received 20-may-2020 indicated the product was not altered in any way prior to use.The problem was discovered when the "patient failing to ventilate due to mucous plug, electively re-intubated.3 failed in sequence (cuff would not remain inflated) resulted in several intubation maneuvers by intensivist md until different box was obtained." resolved by reintubation by provider from a new lot.

• 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: 10097259
• Report Number: 9611594-2020-00086
• Device Sequence Number: 3321287
• Product Code: BTR
• UDI-Device Identifier: 10680651132212
• UDI-Public: 10680651132212
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 03/01/2021
• Device Model Number: 13221
• Device Catalogue Number: 101322102
• Device Lot Number: AA9070V01
• 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: 05/07/2020
• Initial Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 242