MAUDE Adverse Event Report: HALYARD HEALTH 24-HOUR ORAL CARE KIT WITH BALLARD* TECHNOLOGY, Q4 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)
Date of Event	10/24/2017
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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 09nov2017 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 "there was an issue today in which the registered nurse was performing mouth care and during care, the sponge fell off the device and was in the patient's airway.Per the respiratory therapist, the patient's mouth was swollen which made it very difficult to locate the sponge.They were able to remove it, but it took approximately 15 minutes and required the respiratory therapist and the physician assistant." additional information was received on 24-oct-2017 that states, "the patient¿s swollen mouth was a result of injury from a suicide attempt, not due to efforts to retrieve the swab.The customer was completely sedated on a ventilator with an endotracheal tube in place.There was no patient injury and no desaturation." a bite block was in place.No dentition issues noted.No additional information was provided.
Additional Manufacturer Narrative
Based on the investigation the product code was changed to 97014.The sample was returned for evaluation.One sample was received - one suction swab, one swab stick, one unopened pack of mouth moisturizer and one unopened debriding agent.The lot number reported is from the debriding agent.The foam swab is detached from the suction tubing.The green plastic tip remains attached to the distal end of the tube.The foam swab was examined under magnification.No tearing or other defect was observed on the foam.The distal end of the suction tubing was examined under magnification.Adhesive residue was observed on the exterior of the tubing, extending 1.8cm from the tip.When examining all sides of the tubing, it was observed that the adhesive residue is not present on all sides.The foam swab is fully attached to the non-suction stick sample.The device history record for the lot number reported 020710463, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.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: 7014833
• Report Number: 8030647-2017-00132
• Device Sequence Number: 16450976
• Product Code: JOL
• UDI-Device Identifier: 30680651970214
• UDI-Public: 30680651970214
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• 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: Respiratory Therapist
• Device Model Number: 97014
• Device Catalogue Number: 991097021
• Device Lot Number: 0202710463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/11/2017
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 72