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

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 301632457
• Report Number: 3010838917-2022-00015
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752136908
• UDI-Public: (01)10190752136908(10)202746
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention