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

Catalog Number CA25B0/400/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 07/22/2023

Event Type  malfunction  

Event Description

It was reported that during pre-testing, when the anesthesia circuit was set in the anesthesia machine and a leak check was performed, the leak alarm responded.No adverse effects have been reported.

Manufacturer Narrative

Other, other text: d4: udi section, expiration date and h4: manufacture date are not available based on the reported lot number.G5: 510k number is blank, device is exempt.Device evaluation: one device was returned for investigation.Visual inspection revealed a tear in the breathing circuit.Functional testing found minor leakage from the breathing circuit; confirming the complaint.A device history report (dhr) review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.No other anomaly outside of the leak was observed.Therefor it was considered that the leakage occurred before being supplied to manufacturing facilities.To further investigate the cause of the observed condition, the device was forwarded to another investigation site for additional analysis.A supplemental report will be provided when further information becomes available.

Manufacturer Narrative

Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).Secondary component investigation: one device sample was received without the original packaging.Four (4) photos were included for evaluation, photos showed the cosmetic issue.Per visual inspection, it was not possible to detect embedded resin defect in the corrugated tube which could cause the leaking failure mode.A leak test was performed in which a leak was detected in the corrugated tube during the test; the complaint was confirmed.The root cause was manufacturing due to embedded resin caused during the extrusion process.A device history record (dhr) review could not be performed as the lot number was unknown.All mitigations in place were verified and it was confirmed has been executed accordingly.The complaint fault has been escalated to address a full root cause investigation and is currently in the implementation phase.

• 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: 17590510
• MDR Text Key: 321629602
• Report Number: 3012307300-2023-08210
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA25B0/400/000JP
• Device Lot Number: 230705
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1