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, 72 IN LIMBO, 3L BAG
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that while the patient is intubated the anes circuit, adult, 72 in limbo, 3l bag had a plastic barrier which prevented the oxygen from entering the corrugated tube.Alternative ventilation was provided and the customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Result of investigation:the suspect device and photo was visually inspected by quality personnel according to pqas afm1qxxx etal identifying the component part number 65-20009 occluded with a plastic barrier at one of the component's end.It was determined that process may be related with the reported defect since in the procedure, is not indicated that the mold has to go down for cleaning after a time of permanence of plastic inside the mold due to a blackout or problem in machine that may have obstructed the flow of plastic to one of the cavities near the affected one, causing it to over pack.Therefore the root cause was determined.

• 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 INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15609746
• Report Number: 8030673-2022-00274
• Device Sequence Number: 15248669
• Product Code: CAI
• UDI-Device Identifier: 10190752121973
• UDI-Public: (01)10190752121973(10)0004213080
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG
• Device Catalogue Number: AFNX1900
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown