MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a loose connection between the elbow and the hmu filter resulted to a detachment of the gse from edith 1000 hme and edith 1000 hme from the patient wye on the sutter health formulary a5u580a4 vital signs® adult anesthesia breathing circuit, lot 0004188508.Most times the operating time is increased due to the circuit falling apart.And for this reported incident, the issue caused a disruptions and room gas contamination during surgery.The issue occurred during patient-use and at this time, there is no information regarding patient harm associated with the reported event.
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
Results of investigation:the device history record was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.According to investigation, we determined that equipment and material are related to reported defect: mold ( m-166s) is related to reported defect, since found some cavities in the minimum in sample from production and the samples provided for the investigation found some cavities out of specification.The mold was reviewed and found that some cavities are in the minimum and it can cause that some cavities are in the minimum dimensional or out of specification.3 closed samples were received for evaluation and an additional 2 samples were received as well.On the 3 samples received 2 elbows and 1 filter are out of specification.While from the additional samples received 1 elbow and 2 filters are out of specification.Therefore the reported defect was confirmed.The root cause is the material does not meet the manufacturer's specifications.The elbow is manufactured in mexicali while the filter is manufactured and provided by an external supplier.

• Brand Name: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12490642
• Report Number: 8030673-2021-00200
• Device Sequence Number: 19767000
• Product Code: CAI
• UDI-Device Identifier: 10190752120792
• UDI-Public: (01)10190752120792(10)0004188508
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: A5U580A4
• Device Lot Number: 0004188508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 11/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown