MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE EYE-7.5MM ORAL/NASAL MAGILL MURPHY MCUFF; VAP ENDOTRACHEAL TUBES

Model Number	35215
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2014
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 in-progress.Upon completion of the investigation; a follow-up report will be filed.All information reasonably known as of 05jul2017 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).Device not returned.
Event or Problem Description
A medwatch report number (b)(4) was received on 19-jun-2017.It was reported that, a fall/trauma patient in a c-collar was intubated with a glidescope with slight difficulty.The balloon was pre-tested the endotracheal tube passed without complication, and the patient was intubated.Initially with the appropriate pilot balloon inflation with approximately 15cc of air.The respiratory therapist noted the patient possibly had air leak (tidal volume down from 600s to 400s; audible).The pilot balloon was checked and was unable to maintain pressure despite repeated inflations with a syringe.The respiratory therapist attached a 3-way stopcock insufflation port as a cap and the pilot balloon now inflated, improving ventilator volumes (500s).No additional information was provided.
Additional Manufacturer Narrative
Correction: it was reported in the initial complaint that no lot number was provided.Lot number um4057xxx was provided.The device history record was review for lot number um4057xxx that met specifications for all the relevant inspection and tests performed during the manufacturing process.The cause of the leakage cannot be confirmed as there is no sample available for investigation.A root cause could not be identified all information reasonably known as of 31jul2017 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.(b)(6)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 (b)(6) health complaint database and identified as complaint (b)(4).

• Brand Name: ENDOTRACHEAL TUBE EYE-7.5MM 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: 6692929
• Report Number: 9611594-2017-00098
• Device Sequence Number: 10895481
• Product Code: BTR
• UDI-Device Identifier: 30680651352157
• UDI-Public: 30680651352157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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: Respiratory Therapist
• Device Expiration Date: 02/01/2019
• Device Model Number: 35215
• Device Catalogue Number: 991035215
• Device Lot Number: UM4057XXX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/02/2017
• Patient Sequence Number: 1