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

Model Number	35215
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Extubate (2402)
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 03 feb 2020 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 avanos medical inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced six different incidences, which were associated with separate units, involving different patients.This is the fifth of six reports.Refer to 3011270181-2020-00018 for the first report.Refer to 3011270181-2020-00019 for the second report.Refer to 3011270181-2020-00020 for the third report.Refer to 3011270181-2020-00021 for the fourth report.Refer to 3011270181-2020-00023 for the sixth report.It was reported that over the past 21-30 days the user facility experienced multiple incidents of the ett [endotracheal tube] developing tears in the cuff.The tears occurred during use with multiple doctors who were all very familiar with using the product.No patient injuries; however, all incidents required patient to be reintubated.Additional information received from the customer on 28-jan-2020 indicated "we had a total of 6 ett changes due to cuff failure.It was not the same patient each time.The tears were noted in the cuff itself upon removal of the ett, but was not noted prior to inspection.".

• Brand Name: MICROCUFF 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: 9670396
• Report Number: 3011270181-2020-00022
• Device Sequence Number: 14181216
• Product Code: BTR
• UDI-Device Identifier: 10680651352153
• UDI-Public: 10680651352153
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• 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
• Report Date (Section B): 02/05/2020

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 Model Number: 35215
• Device Catalogue Number: 103521505
• 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: 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1