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

Model Number	35111
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 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).Device not returned.
Event or Problem Description
Halyard received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the first of four reports.Refer to 9611594-2017-00006 for the second patient.Refer to 9611594-2017-00007 for the third patient.Refer to 9611594-2017-00008 for the fourth patient.It was reported that there was endotracheal tube obstruction by viscous blood or sputum.This occurred four times.Of those four times, an unknown number required extubation and re-intubation.The remaining incidents were noted upon scheduled extubation, with no re-intubation required.There were no injuries to patients reported.No further information has been provided at this time.

• Brand Name: ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.MM
• Common Device Name: KIMVENT MICROCUFF ET TUBES PEDIATRIC
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6253081
• Report Number: 9611594-2017-00005
• Device Sequence Number: 13473306
• 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
• Report Date (Section B): 12/26/2016

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 Model Number: 35111
• Device Catalogue Number: 991035111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2016
• Initial Report FDA Received Date: 01/16/2017
• Patient Sequence Number: 1