MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	ANES CIRCUIT, ADULT, 60 IN CORR, 3L BAG
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - 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 anes circuit, adult, 60 in corr, 3l bag had a leak after patient use.Furthermore, there is no information regarding patient harm.
Additional Manufacturer Narrative
Result of investigation: the suspect device was returned for product evaluation.The physical sample was functionally inspected by quality personnel from assembly area according to pqas 123adu etal performing a leak test and the sample did not pass the test, finding a hole on the tube part number r5042a.In addition, the device history records of the fg part number 5037ae and the tube part number r5042a were reviewed, and no issues were found during their manufacturing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16949956
• Report Number: 8030673-2023-00321
• Device Sequence Number: 3340126
• Product Code: CAI
• UDI-Device Identifier: 10190752118461
• UDI-Public: (01)10190752118461(10)0004229462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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, ADULT, 60 IN CORR, 3L BAG
• Device Catalogue Number: 5037AE
• Device Lot Number: 0004229462
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/14/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown