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	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical was unable to verify the customer's reported issue.The suspect device is not available for return, as it was discarded.Based on the investigation the reported defect was not confirmed since no picture or sample was provided.Also, we are unable to review the device history record for any issue related to this customer report since the lot number was not provided.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported an incident one month ago with amn520x4f limb--o" single limb anesthesia breathing circuit.Three or four circuits didn't pass the leak test while doing a machine test.And one case during operation, the anesthesia machine showed a circuit leak in the middle of a case and they had to bag the patient but there was no patient harm.

• Brand Name: LIMB--O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11449032
• Report Number: 8030673-2021-00152
• Device Sequence Number: 17235693
• Product Code: CAI
• UDI-Device Identifier: 10190752122987
• UDI-Public: (01)10190752122987
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: LIMB--O¿ SINGLE LIMB ANESTHESI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention