MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 3.0 MM, ORAL/NASAL MAGILL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	991035111
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was originally filed under medwatch 9611594-2018-00112 on 16 aug 2018.However, it was determined that the manufacturer number was used in error, and the correct manufacturer reference number is (b)(4).This new initial report 3011270181-2018-00043 replaces the original initial report 9611594-2018-00112 and all further updates will be filed under this number.One used sample was received for evaluation.The sample was visually inspected and no obvious damage or defect was noted.The cuff was inflated with air and submerged in water.No leakage was seen.The cuff, pilot balloon, and inflation line were all squeezed and manipulated, and no leakage was observed at any point along the inflation pathway.The cuff maintained inflation throughout the evaluation.The complaint could not be confirmed as reported.No root cause could be determined.All information reasonably known as of 27 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that there was a problem with cuff pressure.The pressured dropped after a time.No injury reported.No further information reported.

• Brand Name: MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 3.0 MM, ORAL/NASAL MAGILL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7962499
• Report Number: 3011270181-2018-00043
• Device Sequence Number: 16579284
• Product Code: BTR
• UDI-Device Identifier: 30680651351112
• UDI-Public: 30680651351112
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: 991035111
• Device Catalogue Number: 35111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 10/12/2018
• Patient Sequence Number: 1