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 01/29/2024

Event Type  malfunction  

Event Description

It was reported to vyaire medical that during use on patient, leak occurred on from anes circuit, adult, 72 in limbo, 3l bag.At this time, the customer has not provided any information regarding patient harm or injury 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.The issue occurred on 5 patients.Please see (b)(4) for the other 4 patients.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

Based on the investigation and per pictures sent by the customer of fg afnx2xxx with lot number 0004257698, we confirm the reported defect since in the pictures we can appreciate that the green bag part number r5063ebma (used for the manufacturing of fg afnx2xxx) has a tear confirming the reported defect.Manufacturing equipment might have contributed to the reported defect since issues with the condition of both the molding machine and the mold utilized in the manufacture of the green bag part number r5063ebma were identified.These issues might have caused the green bag to be molded with a thinner wall and a slightly weaker seam in the area where the green bag opened when pressurized by hand.In addition, the device history record with lot number 0004257698 was reviewed as part of the investigation, and no issues related to the reported defect were found.In addition, pfmea-62a-007 was reviewed, and controls were implemented for this type of defect.Based on the above, the reported defect was confirmed, and the root cause was established.

• 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
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18764344
• MDR Text Key: 336872146
• Report Number: 8030673-2024-00380
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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