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, 108 IN LIMBO
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, no investigation was performed as the product was discarded by the hospital due to an infectious disease.Therefore, a definitive root cause could not be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the blue connector on the inhale side and the white connector on the exhalation side (afpxxxxx-anes circuit, adult, 108 in limbo) are connected and used, respectively.The leak test passed without any problems.However, the white connector loosened during the procedure.However, the connector continued to pull out immediately when pulled until the end of the op.There was no particular problem with the blue connector.On follow-up, the customer confirmed that the operation went successfully, but until the end of the operation, the tube kept loose when it was pulled.The customer confirmed that there was no patient harm/injury associated with the event.
Additional Manufacturer Narrative
Based on the investigation, since no pictures or physical samples were provided, we cannot confirm the reported defect.We require the physical sample and/or pictures as evidence to perform a better investigation and determine the cause of the reported issue.Additionally, quality personnel conducted a random sampling in one batch of gas elbow part number r5600eb (used for the manufacture of fg afpxxxxx), finding the component to be acceptable and within specification.In addition, the device history record of the fg part number afpxxxxx with lot number 0004246526 was reviewed, and no issues were found during its manufacturing.In addition, pfmea-56a-038 was reviewed, and controls were implemented for this type of defect.  therefore, the root cause was not confirmed.

• Brand Name: VITAL SIGNS¿ LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Common Device Name: 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: 17993374
• Report Number: 8030673-2023-00356
• Device Sequence Number: 5945758
• Product Code: CAI
• UDI-Device Identifier: 10190752122338
• UDI-Public: (01)10190752122338(10)0004246526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 108 IN LIMBO
• Device Catalogue Number: AFPXXXXX
• Device Lot Number: 0004246526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown