MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS BREATHING CIRCUITS, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN; CIRCUIT, BREATHIG (W CONNECTOR, ADAPTER, Y PIECE)

Model Number	M1090619
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	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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 circuit e(a) 1.8m 1.5m-ext 2l bag gse have leaks.Furthermore, there is no information regarding patient involvement.
Event or Problem Description
It was reported to vyaire medical that the circuit e(a) 1.8m 1.5m-ext 2l bag gse have leaks.Furthermore, there is no information regarding patient involvement.
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if addition information becomes available.Issue was confirmed based on the picture provided by the customer.Based on the picture it is clear that the tube has been damaged.It is however not possible to determine at which point this damage has occurred.It is also not possible to determine if the damage goes through the product causing the leak, but this is possible.Production process includes leak test that would catch a leaking product.Thereby it is very unlikely that the damage would have been caused during production.The most likely cause of the damage is rough handling of the product package, or rough handling of the product by the user.

• Brand Name: VITAL SIGNS BREATHING CIRCUITS, EXPANDABLE, ADULT, DISPOSABLE, 1.8 M/72 IN
• Common Device Name: CIRCUIT, BREATHIG (W CONNECTOR, ADAPTER, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, china ; CH
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18727890
• Report Number: 3010838917-2024-00105
• Device Sequence Number: 6934031
• Product Code: CAI
• UDI-Device Identifier: 10190752136694
• UDI-Public: (01)10190752136694(10)230804
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: M1090619
• Device Catalogue Number: M1090619
• Device Lot Number: 230804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown