MAUDE Adverse Event Report: HALYARD HEALTH KIMVENT 24 HOUR ORAL CARE KIT Q4 16; VAP ORAL CARE PRODUCTS

Model Number	97021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not available for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.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 two different incidences, which were associated with separate units.This is the second of two reports.Refer to 8030647-2017-00040 for the first report.It was reported that, two different nurses reported that the swab came apart and was in the patient's mouth.No injury reported.No additional information provided.

• Brand Name: KIMVENT 24 HOUR ORAL CARE KIT Q4 16
• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6446955
• Report Number: 8030647-2017-00041
• Device Sequence Number: 13660497
• Product Code: JOL
• UDI-Device Identifier: 30680651970214
• UDI-Public: 30680651970214
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/07/2017

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: Nurse
• Device Model Number: 97021
• Device Catalogue Number: 991097021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/30/2017
• Patient Sequence Number: 1