MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL4.MM; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35113
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Respiratory Distress (2045)
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.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.This product incident is documented in the halyard health complaint database and identified as (b)(4).Device not returned.
Event or Problem Description
It was reported that during surgery, there was an obstruction of the endotracheal tube.The patient was extubated and re-intubated.The hospital reports that suctioning had been minimized due to poor patient condition.
Additional Manufacturer Narrative
All information reasonably known as of 16 aug 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Per additional information received 4 aug 2017, the patient was undergoing heart surgery at the time of the reported event.

• Brand Name: ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL4.MM
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6416706
• Report Number: 9611594-2017-00045
• Device Sequence Number: 38807
• Product Code: BTR
• UDI-Device Identifier: 30680651351136
• UDI-Public: 30680651351136
• 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,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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: Health Professional
• Device Model Number: 35113
• Device Catalogue Number: 991035113
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 08/21/2017
• Patient Sequence Number: 1