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

Catalog Number CA24E0/4P6/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Only the month ((b)(6)) and year (2020) of the event date are known.(b)(6).Device evaluation results: one portex general anesthesia circuit was returned for investigation in used condition.Observation of the returned breathing circuit revealed dents and damage.A leak was observed during leak testing.The reported product problem was therefore confirmed.The root cause of the product problem was a manufacturing issue.This was established as the root cause.

Event Description

It was reported that during pre-use check, the customer noticed that air was leaking from the anesthesia circuit.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Four pictures and one sample were returned for analysis.In the fourth picture, the circuit could be seen to have a tear.The returned sample was found to be damaged including a tear.Based on the sample provided, physically evaluation, the most probable cause is that the product became damaged after it left the manufacturing facility.No corrective actions are required since failure mode is not attributable at the manufacturing process since all products are 100% leak tested; if a tear damages a circuit surface couldn't pass the leak test.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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
• MDR Report Key: 11171480
• MDR Text Key: 226851617
• Report Number: 3012307300-2021-00429
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CA24E0/4P6/000JP
• Device Lot Number: 201111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1