MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.5MM; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35112
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.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.(b)(4).
Event or Problem Description
It was reported that it was not possible to inflate the microcuff balloon due to leaks during the mechanical ventilation.This resulted in non optimal ventilation of the patient.No further information has been provided at this time.

• Brand Name: ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.5MM
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6342819
• Report Number: 9611594-2017-00023
• Device Sequence Number: 13703642
• Product Code: BTR
• UDI-Device Identifier: 30680651351129
• UDI-Public: 30680651351129
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/31/2017

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: 35112
• Device Catalogue Number: 991035112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1