MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	AVEA
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).At this time, vyaire has not received the suspect device/component for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire that the avea smartcath ng was inserted into a patient.The rn was unable to deliver medications to the patient through the ng.The rn removed the ng and it was observed that there were no primary or secondary holes in the end of the tube.The customer advised the tubing was replaced and there was no patient harm associated with this event.
Additional Manufacturer Narrative
(b)(4).Customer discarded the actual sample.The customer provided photos which were reviewed.The photos do not clearly exhibit the reported issue, however the customer's claim has been accepted.The current stock in warehouses 6012 and 6021 were visually inspected and no tubes were found to exhibit this issue.The root cause was determined to be a molding defect of the tubing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AVEA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9216331
• Report Number: 2021710-2019-10933
• Device Sequence Number: 387758
• Product Code: CBK
• UDI-Device Identifier: 10846446002683
• UDI-Public: (01)10846446002683
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AVEA
• Device Catalogue Number: 3001042
• Device Lot Number: BD1101
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/26/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other