MAUDE Adverse Event Report: VYAIRE MEDICAL INC. WATER STERILE F/INHAL FLEX 1000ML 14/CS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number	WATER STERILE F/INHAL FLEX 1000ML 14/CS
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device was not yet returned.
Event or Problem Description
It was reported to vyaire medical that the 2d0735x water sterile f/inhal flex 1000ml 14/cs were leaking from the bottom seam of the bag while connected to a patient.There was no patient harm.
Event or Problem Description
It was reported to vyaire medical that the 2d0735x water sterile f/inhal flex 1000ml 14/cs were leaking from the bottom seam of the bag while connected to a patient.There was no patient harm.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.There is no evidence that point that the finish goods were received with leaking product.Each pallet is visually inspected by the dc upon receival and before moved to a storage location and then when retrieved from that location to pack good for shipping to customer site.It is believed that the issue occurred during transportation to customer location.

• Brand Name: WATER STERILE F/INHAL FLEX 1000ML 14/CS
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): LABORATORIES PISA; s.a. de c.v. carretera; san isidro mazatepec; tlajomulco de zuniga, mexico 45FI4 5; MX 45FI45
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17331011
• Report Number: 8030673-2023-00334
• Device Sequence Number: 7404969
• Product Code: BTT
• UDI-Device Identifier: 10190752196445
• UDI-Public: (01)10190752196445(10)02202289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090915
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: WATER STERILE F/INHAL FLEX 1000ML 14/CS
• Device Catalogue Number: 2D0735X
• Device Lot Number: 02202289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown