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

Catalog Number CA25K0/400/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: expiration date and h4: manufacture date are not available.Device evaluation: one device was returned for investigation.Visual observation of the above components revealed no abnormalities.Functional testing found minor leakage from the breathing circuit, confirming the complaint.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.It was determined the leakage occurred at the supplier.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.

Event Description

It was reported that during pre-testing, the device leaked from the circuit.No adverse effects reported.

Manufacturer Narrative

H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Secondary component investigation: one device sample was received in used condition without original package.Three photos were included for evaluation; photos showed the leaking 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, and a leak was detected in the corrugated tube during the leak test; complaint was confirmed.The root cause was manufacturing, caused during the assembly of the tubing to y connector, because at the time of assembly, the connector damaged the inner ring that seals between both parts, causing a slight fracture due to which the air leak occurs.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed has been executed accordingly, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation.

• 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: 17443619
• MDR Text Key: 320235847
• Report Number: 3012307300-2023-07718
• 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: 02/26/2024

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: Health Professional
• Device Catalogue Number: CA25K0/400/000JP
• Device Lot Number: 230228
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/30/2023
• Supplement Dates FDA Received: 02/26/2024
• 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