MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

Model Number	ANES CIRCUIT, ADULT, 72 IN LIMBO
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
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 during surgery the afnxxxxx anes circuit, adult, 72 in limbo had a leak from the tube.The customer confirmed that the tube was changed immediately and that the reported event did not harm the patient.
Additional Manufacturer Narrative
Device evaluation:g3,g6,h2, h3, h6 and h10.Result of investigation:the suspect device and photo was visually inspected by quality personnel from assembly area according to pqas afm1qxxx etal and it was observed that the clear tube part number r5014a came broken, that causing the leak issue.Additionally, it was found that the circuits came without the elbow part number r5600eb.Therefore, the defect reported by the customer was confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Common Device Name: ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; 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: 15886758
• Report Number: 3013421741-2022-00025
• Device Sequence Number: 5122739
• Product Code: CAI
• UDI-Device Identifier: 10190752122239
• UDI-Public: (01)10190752122239(10)0004210125
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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, ADULT, 72 IN LIMBO
• Device Catalogue Number: AFNXXXXX
• Device Lot Number: 0004210125
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/05/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown