MAUDE Adverse Event Report: VYAIRE MEDICAL 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	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that circuit has a loose connection between the elbow and came apart during surgery.The size of the circuit is smaller from than it should be.Anesthesia disconnection was quickly recognized and the circuit was reconnected.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Result of investigation: the customer did not return the physical sample for the investigation; however, customer sent a picture for the investigation.In the picture sent by the customer we can observe the part number r5600eb and the filter part number r557056200 both used for the manufacture of the fg b1754xt4, no defect is found on the picture provided.The device history record were reviewed and no issues were found.For that reason the reported defect was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16268676
• Report Number: 8030673-2023-00295
• Device Sequence Number: 6992768
• Product Code: CAI
• UDI-Device Identifier: 10190752124103
• UDI-Public: (01)10190752124103(10)0004221591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: B1754XT4
• Device Lot Number: 0004221591
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 02/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown