MAUDE Adverse Event Report: HALYARD HEALTH MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 3.5 MM, ORAL/NASAL MAGILL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 15-nov-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.(b)(4).
Event or Problem Description
It was reported that the inflation line broke off into the patient's mouth a day after the patient was intubated.The piece was retrieved by the nurse, however, the patient was extubated and re-intubated.There was no injury to the patient.No further information is available at this time.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 1-dec-17 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
The product involved in the report has been returned for evaluation.The sample was received with no packaging and received with the severed inflation line.This component did not contain a stock code or lot number identification.The length of the severed inflation line measures approximately 18cm, including the inflation port and pilot balloon.The severed end was examined under magnification.The end was jagged and compressed.There appeared to be teeth marks on the outside of the tubing, adjacent to the severed end.The point of separation for the two components appeared to be dented with some possible teeth marks.The reported issue could not be conclusively determined.A root cause was not identified.All information reasonably known as of 20feb2018 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: MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, 3.5 MM, ORAL/NASAL MAGILL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7042656
• Report Number: 9611594-2017-00148
• Device Sequence Number: 1332076
• Product Code: BTR
• UDI-Device Identifier: 10680651351125
• UDI-Public: 10680651351125
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2018

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: Nurse
• Device Model Number: 35112
• Device Catalogue Number: 991035112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 11/15/2017; 01/29/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 12/06/2017; 02/21/2018
• Patient Sequence Number: 1