MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ PEDIATRIC ANETHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	CIRCUIT, PEDI 108" EXP, 2L LF BAG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional 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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the circuit, pedi 108" exp, 2l lf bag passed pre-use check and was used to a patient.The circuit did not stretch at all but simply broke.Furthermore, no harm was done to the patient.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10 result of investigation: the suspect device was returned for evaluation.It was visually inspected by quality personnel from assembly area according to b1717xxx and it was observed that the tubing 108in expandable pediatric 15mm corr tub part number r5108mexa was broken in two parts.Since the leak test verification of the unit is 100% performed in both extrusion and assembly process to detect holes and/or damages that affected the functionality of the product and not enough evidence was found to confirm that the reported defect happened on vyaire facilities, we could not confirm the root cause.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS¿ PEDIATRIC ANETHESIA 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: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16886923
• Report Number: 8030673-2023-00315
• Device Sequence Number: 17677192
• Product Code: CAI
• UDI-Device Identifier: 10190752124035
• UDI-Public: (01)10190752124035(10)0004231466
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: CIRCUIT, PEDI 108" EXP, 2L LF BAG
• Device Catalogue Number: B1717XXX
• Device Lot Number: 0004231466
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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
• Patient Sex: Unknown