MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	FN2444
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing in package is covered in a "sticky" substance.There was an unknown chemical on tubing that could cause unknown reactions with medication, causing unknown complications.Procedure was completed with a different nebulizer tubing.

• Brand Name: AIRLIFE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr; irvine CA 92618
• MDR Report Key: 20368420
• Report Number: 20368420
• Device Sequence Number: 3890330
• Product Code: CAF
• UDI-Device Identifier: 10190752117648
• UDI-Public: (01)10190752117648(17)240905(10)0004111569
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024
• Report Date (Section F): 05/07/2024

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
• Device Model Number: FN2444
• Device Catalogue Number: FN2444
• Device Lot Number: 0004111569
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• 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
• Date Report Sent to FDA: 05/07/2024