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	Break (1069)
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 27-nov-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.(b)(4).
Event or Problem Description
It was reported that a swab sponge on the end of the toothettes were coming off the suction handle in the patient's mouth.The clinician successfully retrieved the swab from the patient's mouth.There was no patient injury reported.
Additional Manufacturer Narrative
Halyard received one (1) used sample that was not returned with the original packaging.The returned sample (1) was placed across the lab table.While visually observing the returned sample, it was clear that a detachment had occurred between the suction tube and suction green sponge.The sample sponge exhibited dark brownish discoloration on some areas of the sponge.Under magnification, the green suction sponge was examined.There were presence of a white looking substance that is similar to a crystallized material on top of the sponge.While reviewing the suction tube, there were materials from the sponge left intact/attached to the suction tube (tip area).A shiny appearance was seen around the suction tubing which looks similar to a bonding agent.Dhr (device history record) review could not be performed since lot number was not provided.Root cause could not be determined, however, process opportunities have been noted.All information reasonably known as of 27-dec-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).

• Common Device Name: VAP ORAL CARE PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7064622
• Report Number: 8030647-2017-00139
• Device Sequence Number: 11225548
• Product Code: JOL
• UDI-Device Identifier: 30680651139048
• UDI-Public: 30680651139048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/06/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 12/27/2017
• Patient Sequence Number: 1