MAUDE Adverse Event Report: NEB KIT W ADAPTER 0.45% NACL 1000ML; HUMIDIFIER NEBULIZER KIT

Model Number	NEB KIT W ADAPTER 0.45% NACL 1000ML
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
The customer reported that the neb kit w adapter 0.45% nacl 1000ml experienced sputtering of water out of the tip of the bottle when mist stopped.As of this time, there is no information regarding patient involvement associated with the reported event.

• Brand Name: NEB KIT W ADAPTER 0.45% NACL 1000ML
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12643922
• Report Number: 8030673-2021-00204
• Device Sequence Number: 19142296
• Product Code: OGG
• UDI-Device Identifier: 10190752152090
• UDI-Public: (01)10190752152090(10)0004177298
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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 0.45% NACL 1000ML
• Device Catalogue Number: CK4510
• Device Lot Number: 0004177298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/16/2021
• 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: Unknown
• Patient Sequence Number: 1