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

Catalog Number C37101329-NLJ

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a leak alarm occurred and use was discontinued.Patient involvement unknown.

Manufacturer Narrative

Other, month and year of event have been provided, day is unknown.Udi number is unknown, no information has been provided to date.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.

Manufacturer Narrative

Other text: h3, h6: event methods, evaluation, and conclusion codes: updated.Four photos of the device and one sample were received for investigation.The reported issue was confirmed during visual inspection, which confirmed there was a hole in the device breathing bag.A review of the manufacturing device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with the reported lot of products.The investigation attributed the root cause of this condition to an issue during the supplier manufacturing process.Complaint information will continue to be monitored and actions assigned as required.

• 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: 17430988
• MDR Text Key: 320115506
• Report Number: 3012307300-2023-07648
• 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

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 4230619
• 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
• Date Manufacturer Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1