MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF* ENDOTRACHEAL TUBE FOR ADULTS, 6.0 MM, ORAL/NASAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35212
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
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 in-progress.All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
User facility report (b)(4) was received and stated, in (b)(6) it was alleged that a patient experience a cuff leak requiring a tube exchange.The endotracheal tube was exchanged on the patient while in the operating room after an anesthesia assessment.A different brand of tube was utilized by anesthesia and there were no further leaks detected.No additional information was provided.
Additional Manufacturer Narrative
The device history record for the lot number,um6046xxx involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The root cause of the issue cannot be determined since there was no sample available to assist the investigation.There were no nonconformance(s), or abnormal conditions noted at the time of production.All information reasonably known as of 03nov2017 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).
Additional Manufacturer Narrative
All information reasonably known as of 27sep2017 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
Additional information received 08-sep-2017 that states, the customer reported the incident event date is (b)(6) 2017 for user facility report # (b)(4).No additional information was reported.

• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6854701
• Report Number: 9611594-2017-00125
• Device Sequence Number: 19009278
• Product Code: BTR
• UDI-Device Identifier: 30680651352126
• UDI-Public: 30680651352126
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2017

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 Expiration Date: 02/01/2021
• Device Model Number: 35212
• Device Catalogue Number: 991035212
• Device Lot Number: UM6046XXX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2017; 10/11/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 09/29/2017; 11/03/2017
• Patient Sequence Number: 1
• Patient Age: 27 YR