MAUDE Adverse Event Report: HALYARD HEALTH HALYARD* ORAL CARE Q2 KIT; VAP ORAL CARE PRODUCTS

Model Number	97020
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	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress; a follow-up report will be filed.All information reasonably known as of 19oct2017 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 nurse was performing oral care on an intubated patient, and the suction swab's foam fell off inside the patient's mouth.The nurse was able to retrieve a piece of foam before going down the airway.There was no adverse outcome reported by the hospital, no injury reported to the patient, and no medical intervention required.No additional information provided.
Additional Manufacturer Narrative
The sample was returned for evaluation.The fal received one (1) used suction swab that was not returned with the original packaging.The returned sample was placed across the lab table.While visually observing the returned sample, it was clear that a breakage had occurred between the suction tip component.Some portion of the suction tip was still intact into the white tube.The green sponge exhibited breakage as well, tearing on some portion of the suction sponge were observed.The device history record for the lot number, m7135a807, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.A root cause was not determined at this time.All information reasonably known as of 11dec2017 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: 6963304
• Report Number: 8030647-2017-00109
• Device Sequence Number: 566346
• Product Code: JOL
• UDI-Device Identifier: 30680651970207
• UDI-Public: 30680651970207
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/16/2017

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 Expiration Date: 09/28/2018
• Device Model Number: 97020
• Device Catalogue Number: 991097020
• Device Lot Number: M7135A807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 12/11/2017
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 36