MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF* ENDOTRACHEAL TUBE FOR PEDIATRICS, 3.0 MM,; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35111
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2017
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 not possible as no lot number was provided.All information reasonably known as of 24 jul 2017 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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
It was reported that the microcuff tube became obstructed by blood and secretions during surgical repair of esophageal atresia.The anesthesiologist immediately noticed the obstruction, and the tube was replaced with a new one.There was no impact on the patient.No further information has been provided at this time.

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6746531
• Report Number: 9611594-2017-00113
• Device Sequence Number: 16190068
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/04/2017

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: Physician
• Device Model Number: 35111
• Device Catalogue Number: 991035111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 07/27/2017
• Patient Sequence Number: 1