MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG

Device Problem Gas/Air Leak (2946)

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

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported to vyaire medical that a leak was found on anes circuit, adult, 72 in limbo, 3l bag during the surgery.The leaking limbo circuit was replaced with a new tube.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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 : device not returned yet.

Manufacturer Narrative

Result of investigation:based on the investigation and per one opened physical sample of fg afnx2xxx with lot number 0004257698, we can confirm the reported defect since the physical sample was functionally inspected by our quality personnel according to pqas afm1qxxx etal, and it was found that the rubber band used for sealing the tubing is not correctly assembled, causing the circuit to leak.Based on the above, we determined that manufacturing personnel may be related to the reported defect if, at the time the fg afnx2xxx was being manufactured, they did not follow the instructions on spm afm1qxxx etal, which indicate the proper way of placing the rubber band part number r504rb to secure the connectors and avoid the circuit from leaking.In addition, pfmea-57a-018 was reviewed, and controls were implemented for this type of defect.Based on the above, the root cause was established and the reported defect was confirmed.

• Brand Name: VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18662535
• MDR Text Key: 334801311
• Report Number: 8030673-2024-00372
• Device Sequence Number: 1
• Product Code: CAI
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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, 3L BAG
• Device Catalogue Number: AFNX2XXX
• Device Lot Number: 0004257698
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention