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 Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
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 in-progress.All information reasonably known as of 13 may 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with the same unit, involving the same patient.This is the third of three reports.Refer to 9611594-2019-00088 for the first report.Refer to 9611594-2019-00089 for the second report.It was reported that "blue connector popped off of the microcuff subglottic et tube.During use.No patient injury.".
Additional Manufacturer Narrative
The device history record for lot aa9014v01 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of 21 jun 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• 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: 8607535
• Report Number: 9611594-2019-00090
• Device Sequence Number: 11265348
• Product Code: BTR
• UDI-Device Identifier: 30680651132216
• UDI-Public: 30680651132216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 05/30/2019

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 Expiration Date: 01/01/2021
• Device Model Number: 13221
• Device Catalogue Number: 101322100
• Device Lot Number: AA9014V01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/24/2019
• Patient Sequence Number: 1