MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 18-sep-2018 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 avanos medical inc complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
Halyard received a single report that referenced three different incidences, which were associated with separate units, involving an unknown number of patients.This is the second of three reports.Refer to 9611594-2018-00151 for the first patient.Refer to 9611594-2018-00153 for the third patient.It was reported that a cuff broke during use.During endotracheal tube (et) replacement a day after starting ventilation, the cuff pressure controller did not stabilize.The patient was extubated and the cuff was found to be broken.A new et was placed for the patient with no injury to the patient noted.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7895213
• Report Number: 9611594-2018-00152
• Device Sequence Number: 14075660
• Product Code: BTR
• UDI-Device Identifier: 10680651132205
• UDI-Public: 10680651132205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/20/2018
• Patient Sequence Number: 1