MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	HUMIDIFIER KIT 500ML 12/CS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.On follow-up, the customer confirmed that when the bottle was attached to the oxygen wall, the water began to bubble out.Two bottles with the same lot number had the same issue.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the nozzle where the nasal cannula is placed does not have a hole to allow oxygen to come out, so pressure builds up in the 002620 - humidifier kit 500ml 12/cs and water comes out of the connector on top.The said issue occurred during use on a patient.The customer confirmed that there was no patient harm/injury associated with the event.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 and h10.Result of investigation: due to the unavailability of photographs, specific quantities of the affected material, and samples available for evaluation, it is not possible to determine the root cause of the event.The results of the functional tests, pivot opening, tightness, thickness monitoring, bottle seal diameter and thickness monitoring, backpressure opening, and statistical inspections by stage, as well as each of the rejections due to defective items identified and segregated during product manufacturing, are available.Test results comply with validated parameters and product specifications.

• Brand Name: AIRLIFE¿ STERILE WATER FOR INHALATION, USP, 500 ML
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): LABORATORIOS PISA; s.a. de c.v. carretera san isi; dro mazatepec # 7000 tlajomulc; jalisco 45645 ; MX 45645
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17880115
• Report Number: 3013421741-2023-00039
• Device Sequence Number: 7389528
• Product Code: BTT
• UDI-Device Identifier: 10190752141643
• UDI-Public: (01)10190752141643(10)TL2303032
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K853146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: HUMIDIFIER KIT 500ML 12/CS
• Device Catalogue Number: 002620
• Device Lot Number: TL2303032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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