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	09/15/2021
Type of Reportable Event	Malfunction
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
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.
Additional Manufacturer Narrative
Results of investigation: no sample was returned; therefore a definitive root cause could not be determined.During the dhr review it was corroborated that process parameters were executed according to the validated standards, raw materials and components used for the manufacturing were approved by the quality unit.Based on the aforementioned, it was determined that manufacturing process was not identified as a failure mode.Retention samples were also reviewed and residues of any type were not detected during the review of the samples.

• 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 S.A. DE C.V.; 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: 14459601
• Report Number: 3007502289-2022-00007
• Device Sequence Number: 4569804
• Product Code: BTT
• UDI-Device Identifier: 10885403026607
• UDI-Public: (01)10885403026607(10)Q2107989
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/21/2022

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
• Device Lot Number: Q2107989
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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