MAUDE Adverse Event Report: VYAIRE MEDICAL WATER STERILE FOR INHALATION 500ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	WATER STERILE FOR INHALATION 500ML
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	Cough (4457)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.If additional information becomes available.
Event or Problem Description
The customer reported that the cn0005 water sterile for inhalation 500m, water smells like fruit punch and is making the patient cough a lot.

• Brand Name: WATER STERILE FOR INHALATION 500ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): LABORATORIOS PISA S.A. DE C.V.; calle 7 n0. 1308; zona industrial; guadalajara jalisco, 44940 ; MX 44940
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14190933
• Report Number: 3005440755-2022-00001
• Device Sequence Number: 4474349
• Product Code: CAF
• UDI-Device Identifier: 10190752141780
• UDI-Public: (01)10190752141780(10)ZI-2108234
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: WATER STERILE FOR INHALATION 500ML
• Device Catalogue Number: CN0005
• Device Lot Number: ZI-2108234
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown