MAUDE Adverse Event Report: VYAIRE MEDICAL LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that anesthesia circuit would not seal either by masking or after intubation, upon further inspection the circuit had two separate holes causing the "leak".Circuit was replaced and old one with holes was set aside, this is prolonged the operating time.
Additional Manufacturer Narrative
The suspect device is not available for investigation.The photo analysis and device history record will be reviewed to determined the root cause of the reported issue.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
The device history record for the part number axxxxx61 with lot number 0004185589 and udi code (b)(6) was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured inspected and released on 07may2021 per our internal procedures and no issues were found.Based on the investigation since no sample or pictures were provided for the investigation, we could not confirm the reported defect.Sample is needed for a a better investigation by performing a leak test on the sample.Therefore, the root cause was not determined.In addition pfmea 57a was reviewed and we have the controls for this kind of issues.Since the defect was not confirmed and the root cause was not determined, no corrective or preventive actions will be taken.

• Brand Name: LIMB-O¿ SINGLE LIMB 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: 12865457
• Report Number: 8030673-2021-00219
• Device Sequence Number: 4425965
• Product Code: CAI
• UDI-Device Identifier: 10190752123311
• UDI-Public: (01)10190752123311(10)0004185589
• 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): Unknown
• 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): 10/28/2021

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: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AXXXXX61
• Device Lot Number: 0004185589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• 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