MAUDE Adverse Event Report: PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. ANES CIRCUIT, PED, 108 IN EXP, 1L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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.
Event or Problem Description
It was reported to vyaire medical that the b1714xxx anes circuit, ped, 108 in exp, 1l bag was leaking.The product was in the process of being attached to the patient when the damage was found.It was noticed when the tubing was extended and the anesthesia gas began to leak.A new circuit was obtained and used in place of the faulty product.There was no harm but this issue cause a delay of treatment.
Additional Manufacturer Narrative
Results of investigation: the suspect device was returned to vyaire medical.The unit was functionally inspected by quality personnel from the assembly area, who performed a leak test on the sample, which failed.It was discovered that the tube part number r5108mexa had a hole, which was causing the leak issue.The root cause was identified and traced back to the operational context that caused or contributed to the event.

• Brand Name: ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque industrial; mexicali,21397 ; MX
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 510 technology dr; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16554284
• Report Number: 8030673-2023-00303
• Device Sequence Number: 4947819
• Product Code: CAI
• UDI-Device Identifier: 10190752124004
• UDI-Public: (01)10190752124004(10)0004223761
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004223761
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/13/2023
• 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
• Patient Sex: Unknown