MAUDE Adverse Event Report: HALYARD HEALTH 24-HOUR ORAL CARE KIT WITH BALLARD* TECHNOLOGY, Q2 WITH CHG; VAP ORAL CARE PRODUCTS

Model Number	97012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 29-nov2017 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
Halyard received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 8030647-2017-00150 for the first patient.Refer to 8030647-2017-00152 for the third patient.It was reported that the swab tip on the suction handle came off in the patient's mouth.This event happened three times in two days.The swab tip was able to be retrieved from the patient's mouths without injury to the patients.No further information was received.

• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7072407
• Report Number: 8030647-2017-00151
• Device Sequence Number: 944459
• Product Code: JOL
• UDI-Device Identifier: 30680651139048
• UDI-Public: 30680651139048
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: 101390402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/30/2017
• Patient Sequence Number: 1