MAUDE Adverse Event Report: HALYARD HEALTH HALYARD* ORAL CARE Q4 KIT WITH CHG; VAP ORAL CARE PRODUCTS

Model Number	97014
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 27oct2017 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 10 different incidences, which were associated with separate units, involving ten different patients.This is the sixth of ten reports.Refer to 8030647-2017-00121 for the first patient.Refer to 8030647-2017-00122 for the second patient.Refer to 8030647-2017-00123 for the third patient.Refer to 8030647-2017-00124 for the fourth patient.Refer to 8030647-2017-00125 for the fifth patient.Refer to 8030647-2017-00127 for the seventh patient.Refer to 8030647-2017-00128 for the eighth patient.Refer to 8030647-2017-00129 for the ninth patient.Refer to 8030647-2017-00130 for the tenth patient.It was reported by the distributor that reports "dear vendor, please review and provide a response to the product quality issue reported.The green sponge breaks off when use and has occurred ten times.There were no injuries reported.Additional information was received from the customer on 02-aug-2017 that states, there was no situation of patient harm to report for any of the incidents cited.Therefore, the staff did not record any information regarding the patient,and no medical intervention was performed in any incident.The only "intervention" would have been removing pieces of the foam swab from the patients' mouths.However, this was not recorded in writing by the staff- only anecdotal accounts.Additional information was requested but not received.

• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6982937
• Report Number: 8030647-2017-00126
• Device Sequence Number: 18962392
• Product Code: JOL
• UDI-Device Identifier: 30680651139031
• UDI-Public: 30680651139031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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: Other Health Care Professional
• Device Model Number: 97014
• Device Catalogue Number: 991013903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 10/27/2017
• Patient Sequence Number: 1