MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.MM; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35111
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample was received for evaluation.The sample appeared clean without any biologic matter or substance.The tubing and assembly were inspected with the naked eye, no visible damage seen.The cuff was inflated, no leakage was observed from the cuff or pilot balloon assembly when submerged and infused with water.The skive in the outer wall of the endotracheal (et) tube was noted to be present.The et tube was then submerged in water, water was blown through the et tube to determine if leakage was present (by presence of bubbles in the water).Bubbles were observed on the skive by the inflation line.When checked under magnification (50x), a small hole was observed on the et tube inside the tubing skive.Investigation into root cause is ongoing.A follow up report will be submitted when the investigation is completed.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.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 there was a hole on endotracheal tube near where the point cuff inflation line is inserted to endotracheal tube.The patient was intubated at 7 p.M.On (b)(6) and the event occurred at 1 a.M.On (b)(6).The leak occurred during use, so doctor checked the tube and found a hole.The patient was reintubated with a new endotracheal tube.There was no injury to the patient.No further information has been provided.
Additional Manufacturer Narrative
Based on the sample evaluation, the small hole observed on the endotracheal (et) tube inside the tubing skive close to joining part between inflating tube and et tube is the cause for the leakage.The skive was created during the cropping & notching process.However, no specific manufacturing root cause could be determined.The device history record for um6o19xxx was reviewed and the product was produced according to product specifications.All information reasonably known as of 15 aug 2017 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).

• Brand Name: ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.MM
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6389310
• Report Number: 9611594-2017-00035
• Device Sequence Number: 603767
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/26/2017

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: 01/01/2021
• Device Model Number: 35111
• Device Catalogue Number: 991035111
• Device Lot Number: UM6O19XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 08/17/2017
• Patient Sequence Number: 1