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

Model Number C37101307J

Device Problem Leak/Splash (1354)

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

Event Date 06/24/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, an air leak alarm sounded.No patient injury.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Unit was returned for evaluation of the failure and pictures provided by the customer.Unit returned was received inside of a plastic bag which was not the original package.Sample was submitted to leak test inspection per specification.Leak test inspection was performed on the returned device using equipment manometer.The device presented leakage.Based on the leak test results, the reported nonconformance was confirmed.The root cause of the reported was most likely the use of the adult nozzle on the extrusion machine, which causes buildup of resin, due to the larger design of the nozzle tip, generating embedded lines throughout sections of circuit rings, resulting in leakage failures.Containment actions were implemented after the manufacturing date of the lots reported by the customer.Containments: occurrence? implemented on august 10,2021.Nozzle cleaning at the beginning of shift and document in format fm-tijsop407-01 remove adult nozzle from process line.Segregate from manufacturing area.These actions have been followed through a quality alert detection? implemented on july 15,2021.All involved personnel were notified of the customer complaints, and instructed to notify quality representative if any product observed embedded lines throughout circuit rings was detected - quality alert.Corrective and preventive actions was established through investigation non conformance report (ncr).

• 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 MN CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 4-1-5, izumi-chuo, izumi-ku,; minneapolis, MN 55442
• MDR Report Key: 12266834
• MDR Text Key: 264730603
• Report Number: 3012307300-2021-07985
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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 Model Number: C37101307J
• Device Catalogue Number: C37101307J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/22/2021
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1