MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ¿ 0.45% SODIUM CHLORIDE INHALATION SOLUTION, US; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	SODIUM CHLORIDE SOLUTION 0.45% 500ML
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that white fluffy particles were found only in one bottle of sodium chloride solution 0.45% 500ml and the customer wants to know the identity of the particles in order to make sure they are truly inorganic.(vs.Micro-organism).It seems the customer discovered the floaters while in use of this saline.She then sub-cultured (negative growth) a sample and kept using till the end.The customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
H3: 81 other:the customer did not send the physical sample.Dhr review assures that all the defectives were correctly segregated and all the product delivered fulfills quality requirements and product's general specifications.Additionally, results of functional tests performed as part of the process control were within specification; including integrity and compressibility tests.Endotoxins and sterility test met specifications as well.H3 : device was not returned.

• Brand Name: AIRLIFE ¿ 0.45% SODIUM CHLORIDE INHALATION SOLUTION, US
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA; carretera san isidro; mazatepec 7000 ; MX 7000
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17206384
• Report Number: 3013421741-2023-00033
• Device Sequence Number: 6666477
• Product Code: CAF
• UDI-Device Identifier: 10190752141766
• UDI-Public: (01)10190752141766(10)ZI-2009274
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K901301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: SODIUM CHLORIDE SOLUTION 0.45% 500ML
• Device Catalogue Number: CN4505
• Device Lot Number: ZI-2009274
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown