MAUDE Adverse Event Report: HALYARD HEALTH KIMVENT 24-HOUR ORAL CARE KIT Q2 WITH CHG; VAP ORAL CARE PRODUCTS

Model Number	97012
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product is available but has not been returned yet.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 15jun2017 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).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 first of two reports.Refer to 3006646024-2017-00013 for the second report.It was reported that, "brushes are breaking off in the patient's mouth.The suction handle comes apart while in use and the patient's lips are more dry than before.The suction tip provides the staff with difficulty in suctioning out the entire oralphyrnagel area." no additional information has been provided.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Brand Name: KIMVENT 24-HOUR ORAL CARE KIT Q2 WITH CHG
• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6659104
• Report Number: 3006646024-2017-00012
• Device Sequence Number: 964373
• Product Code: JOL
• UDI-Device Identifier: 30680651139048
• UDI-Public: 30680651139048
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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 Model Number: 97012
• Device Catalogue Number: 991013904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 09/13/2017
• Patient Sequence Number: 1