MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE EYE-7MM ORAL NASAL MAGILL MURPHY MCUFF; VAP ENDOTRACHEAL TUBES

Model Number	35214
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2017
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 04apr2017 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported on 15-mar-2017 by fda user facility report: (b)(4) that a patient was intubated with an endotracheal tube (ett) for several days.The ventilator is on a heated circuit.The heated circuit heats up the endotracheal tube causing it to become pliable.The tube is noted to bend easily causing kinking.There were no reports of adverse effects to the patient or required medical intervention.Additional information was received on 20-mar-2017 from the initial reporter that states, there is no additional information available at this time to report.

• Brand Name: ENDOTRACHEAL TUBE EYE-7MM ORAL NASAL MAGILL MURPHY MCUFF
• Common Device Name: VAP ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6462839
• Report Number: 9611594-2017-00064
• Device Sequence Number: 849839
• Product Code: BTR
• UDI-Device Identifier: 30680651352140
• UDI-Public: 30680651352140
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K050803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2017

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: Other
• Device Model Number: 35214
• Device Catalogue Number: 991035214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Patient Sequence Number: 1
• Patient Age: 73 YR