MAUDE Adverse Event Report: VYAIRE MEDICAL NEB KIT W ADAPTER STERILE WATER 1000ML; PREFILLED AND DRY LARGE VOLUME NEBULIZER

Model Number	NEB KIT W ADAPTER STERILE WATER 1000ML
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the neb kit w adapter sterile water 1000ml experienced sterile water spitting out from the water and entering the corrugated tubing that is attached to the patient.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
The suspect device has not been returned for evaluation.The customer stated that it was already disposed as this is potentially infectious.Therefore, no root cause could be determined.Pma/ 510(k): enforcement discretion.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: NEB KIT W ADAPTER STERILE WATER 1000ML
• Common Device Name: PREFILLED AND DRY LARGE VOLUME NEBULIZER
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12780829
• Report Number: 8030673-2021-00209
• Device Sequence Number: 11733721
• Product Code: OGG
• UDI-Device Identifier: 10190752158450
• UDI-Public: (01)10190752158450(10)4138942
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: NEB KIT W ADAPTER STERILE WATER 1000ML
• Device Catalogue Number: CK0010
• Device Lot Number: 4138942
• 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: 10/12/2021
• Initial Report FDA Received Date: 11/09/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown