MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT, SINGLE LIMB; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C1034J

Device Problem Gas/Air Leak (2946)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d4: udi section is unknown.G5: 510k is blank, device is 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.

Event Description

It was reported that during pre-testing there was a leak somewhere in the circuit.Although several anesthesia machines were connected, a leak test found the problem.No adverse effects have been reported.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(4).One device sample was received without its original packaging.Three photos were included for evaluation; photos showed perforated tube in the complaint sample.Per visual inspection, it was not possible to detect any damage or perforation in the breathing circuit assembly.A leak test was performed, and a leak was detected in the breathing circuit assembly during the test; the complaint was confirmed.A root cause is unknown and could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The complaint fault has been escalated to address a full root cause investigation and is currently in the investigation phase.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT, SINGLE LIMB
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17957855
• MDR Text Key: 325950233
• Report Number: 3012307300-2023-09718
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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: Health Professional
• Device Catalogue Number: C1034J
• Device Lot Number: 4342977
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1