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

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

Event Type  malfunction  

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 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
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA; carretera san isidro mazatepec; 7000 tlajomulco de zúñiga; jalisco, 45645 ; MX 45645
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 10652991
• MDR Text Key: 222416671
• Report Number: 3007502289-2020-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 20885403164849
• UDI-Public: (01)20885403164849(10)2003074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1