MAUDE Adverse Event Report: VYAIRE MEDICAL WATER STERILE F/INHALATION 2000ML 6/CS; STERILE SOLUTION STORAGE BOTTLE, SINGLE-USE

Model Number	WATER STERILE F/INHALATION 2000ML 6/CS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the water sterile f/inhalation 2000ml 6/cs experienced deposits in the chamber during use.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Vyaire complaint #: (b)(4).Results of investigation: the manufacturer performed a failure investigation through photographic evidence provided by the customer.Functional, integrity and compressibility tests were performed and found to be within specifications.The device history review (dhr) did not identify any deviations that could have resulted in failure.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: WATER STERILE F/INHALATION 2000ML 6/CS
• Common Device Name: STERILE SOLUTION STORAGE BOTTLE, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): LABORATORIOS PISA; sa de cv carretera san isidro; 7000 tlajomulco de zúñiga; jalisco, 45645 ; MX 45645
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12661884
• Report Number: 3007502289-2021-00006
• Device Sequence Number: 14527710
• Product Code: BTT
• UDI-Device Identifier: 10885403026607
• UDI-Public: (01)10885403026607(10)Q2103853
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: WATER STERILE F/INHALATION 2000ML 6/CS
• Device Catalogue Number: 2D0737
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown