MAUDE Adverse Event Report: HALYARD HEALTH ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL4.MM; MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL

Model Number	35113
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 14-sep-17 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 (b)(4).Device not returned.
Event or Problem Description
It was reported that the tube was inserted, the cuff failed to inflate.Per additional information received on 13 sep 2017, the cuff was not pretested prior to insertion.There was no injury to the patient, no bleeding, tissue damage, or skin irritation.Another tube was used to intubate, with pre-test of the cuff prior to insertion.No further information has been provided at this time.
Additional Manufacturer Narrative
The device history record for um6210xxx was reviewed and the product was produced according to product specifications.All information reasonably known as of 4-oct-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).

• Brand Name: ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL4.MM
• Common Device Name: MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6875398
• Report Number: 9611594-2017-00129
• Device Sequence Number: 1312784
• Product Code: BTR
• UDI-Device Identifier: 10680651351132
• UDI-Public: 10680651351132
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 10/03/2017

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: 07/01/2021
• Device Model Number: 35113
• Device Catalogue Number: 991035113
• Device Lot Number: UM6210XXX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/12/2017
• Patient Sequence Number: 1