MAUDE Adverse Event Report: VYAIRE MEDICAL INC. ANES CIRCUIT, LIMBO, 108 IN, 2L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ANES CIRCUIT, LIMBO, 108 IN, 2L BAG

Device Problem Leak/Splash (1354)

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

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

H3: 81 other - at this time, the suspect device is not been returned for evaluation, as it was contaminated.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.H3 other text : the sample is not available for return.

Event Description

It was reported to vyaire medical that the azfcx7xxx anes circuit, limbo, 108 in, 2l bag anesthesia breathing circuit developed a ¿major leak¿ after being in use for 1 hour.The circuit was replaced and there is no information regarding patient harm or injury associated with the reported event.

• Brand Name: ANES CIRCUIT, LIMBO, 108 IN, 2L BAG
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. 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
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16640096
• MDR Text Key: 312284625
• Report Number: 8030673-2023-00309
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752123434
• UDI-Public: (01)10190752123434
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2023

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
• Device Operator: Health Professional
• Device Model Number: ANES CIRCUIT, LIMBO, 108 IN, 2L BAG
• Device Catalogue Number: AZFCX7XXX
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/29/2023
• 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