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

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that during testing, the anesthesia machine leak check did not pass.A leak was detected.No harm/adverse event reported.

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.

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
• Type of Device: 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
• MDR Text Key: 333521000
• Report Number: 9617604-2024-00061
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: (01)15019315075834(17)260415(10)4392928
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 450952-NL
• Device Lot Number: 4392928
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2024
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1