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

Catalog Number CA13E0/400/000JP

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

Month and year of event have been provided; exact dates of occurrence are unknown.H4: manufacture date are not available based on the reported lot number.510k is blank, device is exempt.Device evaluation: the complaint product itself was not returned.One (1) original unopened package with the same lot number was returned for investigation.Observation and functional testing of these components revealed no anomalies such as damage related to the reported event.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.The reported event was not confirmed.We will notify manufacturing site of the occurrence of this event and record this event in our database to monitor the future complaint trends.

Event Description

It was reported that during pre-testing the device had an air leak.The circuit will be set up before surgery and tested to see if there is an air leak, but there is a leak from somewhere and the test will not pass.It was thought that the leaking was coming from the bag.It was reported this event occurred 2-3 times with the same lot number.Adverse effects have not been reported.

• Brand Name: PORTEX ANESTHESIA EXPANDABLE 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: 17557117
• MDR Text Key: 321539567
• Report Number: 3012307300-2023-08163
• 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
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA13E0/400/000JP
• Device Lot Number: 230502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1