MAUDE Adverse Event Report: VYAIRE MEDICAL ANES CIRCUIT, PED, 108 IN EXP, 1L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to vyaire medical that the anesthesiologist was unable to give positive pressure ventilation with the anesthesia machine while vital signs¿ pediatric anesthesia breathing circuit was in use.The patient was suctioned, re-intubated, and was continued to be ventilated by bag valve mask.The customer confirmed that no harm was done to the patient because the anesthesiologist was quick to give medical intervention.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Result of investigation: based on the investigation and per sample received, we determined that after sample was visually inspected by quality personnel according to pqas 5161e etal and no defects were found.Also sample received was functionally inspected by quality personnel according to pqas r5060ebma etal, the following test were performed: leak test.Dilatation test.Concentricity test.Cycle test.On all the test performed, sample resulted acceptable, no defect was found.For that reason, the reported defect and root cause were not confirmed.Pfmea-62a-006 was reviewed but since no defect was found, we could not associate it with an existing failure mode.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ANES CIRCUIT, PED, 108 IN EXP, 1L BAG
• 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 n; o. 85, parque undustrial; mexicali ; MX
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16236151
• Report Number: 8030673-2023-00293
• Device Sequence Number: 15083436
• Product Code: CAI
• UDI-Device Identifier: 10190752124004
• UDI-Public: (01)10190752124004(10)0004221051
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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, PED, 108 IN EXP, 1L BAG
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004221051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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