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	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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.If additional information becomes available.
Event or Problem Description
The customer reported that the airlife¿ modudose¿ 0.9% sodium chloride solution, usp 5 ml is molded together and will not break apart for single use.There are 4 singles molded together and must be cut apart with a box cutter to use.The customer confirmed that there was no harm associated with the reported event.

• 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: 11399874
• Report Number: 3007502289-2021-00001
• Device Sequence Number: 2384893
• Product Code: CAF
• UDI-Device Identifier: 20885403164849
• UDI-Public: (01)20885403164849(10)MPN80023553
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: AIRLIFE¿ MODUDOSE¿ 0.9% SODIUM CHLORIDE SOLUTION, USP 5 ML
• Device Catalogue Number: 5257
• Device Lot Number: MPN80023553
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1