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

Device Problem Leak/Splash (1354)

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

Event Date 04/17/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 315457086
• Report Number: 8030673-2023-00321
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752118461
• UDI-Public: (01)10190752118461(10)0004229462
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1