MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE EYE-8MM ORAL NASAL MAGILL MURPHY MCUFF; VVAP ENDOTRACHEAL TUBES

Model Number	35216
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed 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 25apr2017 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 that after being intubated with an 8.0 microcuff endotracheal tube (ett) on (b)(6) 2017, the patient had to be extubated and reintubated with an ett tube with a polyvinyl chloride cuff from a different manufacturer (sheridan).The removed 8.0 microcuff appeared to have been damaged or torn away from the tube itself.Per additional information received, there was difficulty with the intubation, and the clinician then used the stylet with a glidescope.With the cuff pressure was initially checked it read 50 cmh2o, then was reduced to 30 cmh2o.No bite block or oral airway was used.The patient vomited during post intubation attempts.No further information.
Additional Manufacturer Narrative
All information reasonably known as of 25may2017 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.(b)(4).
Event or Problem Description
Additional information was received on 25apr2017 that states, the initial tube was placed on (b)(6) 2017 and not (b)(6) 2017 as previously reported.The exchange for the second tube took place on (b)(6) 2017.Mw5068957 was received on 26apr2017.No additional information was provided.
Additional Manufacturer Narrative
The sample was returned and evaluated.The sample was received with no packaging.The sample was examined under ambient light conditions.The cuff exhibits an inverted "u" shape tear.The cuff material was manually pressed back into position to assess if any material was missing.The sample appears to have the complete cuff present, with no missing, detached portions.Both the proximal and distal cuff collars are intact and securely attached to the outer tube wall.There was no definitive root cause determined.All information reasonably known as of 22jun2017 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.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).

• Brand Name: ENDOTRACHEAL TUBE EYE-8MM ORAL NASAL MAGILL MURPHY MCUFF
• Common Device Name: VVAP ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6526123
• Report Number: 9611594-2017-00067
• Device Sequence Number: 1345073
• Product Code: BTR
• UDI-Device Identifier: 30680651352164
• UDI-Public: 30680651352164
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K050803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2017

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: Physician
• Device Model Number: 35216
• Device Catalogue Number: 991035216
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/25/2017; 06/26/2017
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 91