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

Catalog Number C49101320J

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.D4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank, 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 additional reportable information becomes available.

Event Description

It was reported that a leak alarm occurred and use was discontinued.When another circuit was installed, it could be used it without any problems.Patient involvement unknown.

Manufacturer Narrative

H3, h6: event methods, evaluation, and conclusion codes: updated.One device was received for investigation.During visual inspection, no damage or anomalies were observed with the device.The device was functionally tested, and no leakage was observed from the sample device.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the investigation could not confirm the reported complaint or assign a root cause.No actions have been assigned at this time.

• 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
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17430985
• MDR Text Key: 320093555
• Report Number: 3012307300-2023-07647
• 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: 08/24/2023

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: C49101320J
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/20/2023
• Supplement Dates FDA Received: 08/24/2023
• 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