MAUDE Adverse Event Report: VYAIRE MEDICAL OY CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN; ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

Model Number	CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
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 they noticed minor leaked on m1152226 - circuit coax (a) 2.4m, b.Ext, 2l bag gse intra-operatively.Initially, machine tested passed without leak.They changed out the circuit at the end of case and they encountered slight delay as new circuit was needed to be applied.The patient was stable before and after the case.

• Brand Name: CO-AXIAL BREATHING CIRCUIT, ADULT, DISPOSABLE, 2.4 M/96 IN
• Common Device Name: ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan, 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15592208
• Report Number: 3010838917-2022-00015
• Device Sequence Number: 16723216
• Product Code: CAI
• UDI-Device Identifier: 10190752136908
• UDI-Public: (01)10190752136908(10)202746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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: CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE
• Device Catalogue Number: M1152226
• Device Lot Number: 202746
• 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: 09/14/2022
• Initial Report FDA Received Date: 10/12/2022
• 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