MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.However, the customer has no response to follow up's regarding the availability of the sample for evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical by a private consumer that she feels that the airlife modudose 0.9% sodium chloride solution, usp 5 ml may be leaching through plastic containers during storage or transit.The customer is highly sensitive to chemicals, having autoimmune mast cell disease.She is unable to use the nebulizer as instructed since it does not smell normal and she can smell and taste a chemical smell when she performs the nebulizer.As of this time, there is no information regarding patient harm.

• Brand Name: AIRLIFE MODUDOSE 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10652991
• Report Number: 3007502289-2020-00001
• Device Sequence Number: 3933570
• Product Code: CAF
• UDI-Device Identifier: 20885403164849
• UDI-Public: (01)20885403164849(10)2003074
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K830943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
• Device Catalogue Number: 5257
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1