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

Device Problem Leak/Splash (1354)

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

Event Date 11/01/2022

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 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.

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
• Type of Device: 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
• MDR Text Key: 304538181
• Report Number: 3013421741-2022-00025
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752122239
• UDI-Public: (01)10190752122239(10)0004210125
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 01/05/2023
• 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