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

Model Number ANES CIRCUIT, ADULT, 60 IN LIMBO, 3L BAG

Device Problem Material Deformation (2976)

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

Event Date 09/13/2023

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 the the agrx2xxx - anes circuit, adult, 60 in limbo, 3l bag inflates unevenly.On follow-up, the customer confirmed that when the gas was injected into the bag, a lump had formed.Although the amount of gas sent was monitored (pressure applied was 40 h20, which is in a normal range), they were hesitant to use the bag because it may require a different force compared to using a normal bag.Surrounding nurses also commented that the inflated area was so thin that they could see through it, and they were worried it would burst or leak later on after use.The customer confirmed that no patient was involved.

Manufacturer Narrative

Vyaire medical file identification:(b)(4).Result of investigation: based on the investigation and since the customer did not send a physical sample, however, the customer did send pictures of the fg part number agrx2xxx with a lot number unknown for the investigation.In the picture received, we can see a deformity on the upper part of the component green bag part number r5063ebma, and we can confirm the reported defect.Subsequently, the customer sent one opened physical sample of fg agrx2xxx with a lot number unknown for the investigation.The physical sample was functionally tested by quality personnel from the assembly area according to pqas r5060ebm etal, who performed a leak test to inspect the deformity.The physical sample was unacceptable since the green bag has a deformity on the upper part, filling unevenly, confirming the reported defect.In addition, a concentricity test was performed, and the physical sample passed the test.Equipment might have contributed to the reported defect since, at the time of the manufacture of component green bag part number r5063ebma, the molding machine had a problem with alignment, which caused the reported defect.In addition, manufacturing personnel might have contributed to the reported defect if, at the time of manufacture, they did not follow the instruction according to spm r5060ebma, which states, ""when the bags are inflated completely and until the indicator is turned on, the operator will inspect the parts for defects."".Based on the above, the root cause 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 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17927823
• MDR Text Key: 325582131
• Report Number: 8030673-2023-00355
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752122833
• UDI-Public: (01)10190752122833(10)0004242363
• 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: 10/12/2023

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 LIMBO, 3L BAG
• Device Catalogue Number: AGRX2XXX
• Device Lot Number: 0004242363
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/01/2023
• 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