MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13222
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot aa8295v01 was reviewed and the product was produced according to product specifications.All information reasonably known as of 07 aug 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 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 three different patients.This is the second of three reports.Refer to 9611594-2020-00149 for the first report.Refer to 9611594-2020-00151 for the third report.It was reported that "the cuff broke while blocking/pumping it up." there was no reported injury.No further information provided.Per additional information received 10-aug-2020, the cuff broke during ventilation.The device had previously been intact.The patient was re-intubated, and was inadequately ventilated for a short period, but this did not lead to any change in patient condition.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10391207
• Report Number: 9611594-2020-00150
• Device Sequence Number: 11498617
• Product Code: BTR
• UDI-Device Identifier: 00609038132228
• UDI-Public: 00609038132228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: 10/01/2020
• Device Model Number: 13222
• Device Catalogue Number: N/A
• Device Lot Number: AA8295V01
• 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: 07/24/2020
• Initial Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1