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

Catalog Number C37101330-NLJ

Device Problem Leak/Splash (1354)

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

It was reported that there was a leak from the anesthesia bag during pre-test.

Manufacturer Narrative

Other text: b3: month and year of event have been provided ,day is unknown, d4: udi number, g5: 510k, 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 required.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Device evaluation: returned sample was received without original packaging.During a visual inspection, it was possible to detect embedded resin defect in the corrugated tube which could cause the leaking failure mode.During the functional testing, there were no air leaks found during the breathing bag test.The result of the corrugated tubing assembly test was not acceptable as there was an air leak due to the embedded resin defect.The leaking issue was detected in the corrugated tube during the leak test and the complaint was confirmed.Based on the analysis conducted in the sample provided, the embedded resin was confirmed.The problem was likely caused during the extrusion process.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT
• 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: 17614816
• MDR Text Key: 321869127
• Report Number: 3012307300-2023-08387
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101330-NLJ
• Device Lot Number: 4358080
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1