MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ANESTHESIA BREATHING SYSTEM, EXPANDABLE CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number	450952-NL
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, the anesthesia machine leak check did not pass.A leak was detected.No harm/adverse event reported.
Additional Manufacturer Narrative
E2 - incorrect due to system limitations.Initial reporter is account sales representative.G5: product code cai is 510k exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one device and three photos were received for investigation.A pinhole was observed in the bag in picture 3 and was also seen during visual inspection of the device.The failure mode was confirmed.Based on the analysis conducted in the samples provided, the breathing bags present a damage.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.Root cause cannot be established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX ANESTHESIA BREATHING SYSTEM, EXPANDABLE CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18537239
• Report Number: 9617604-2024-00061
• Device Sequence Number: 7773575
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: (01)15019315075834(17)260415(10)4392928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: Other
• Device Expiration Date: 04/15/2026
• Device Catalogue Number: 450952-NL
• Device Lot Number: 4392928
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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