MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number C37101678D-NL

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(udi) and (510k) are unknown.No additional information was provided.This mdr was generated under protocol b10009704, as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four (4) samples were received with their opened original packaging inside a plastic bag.A leak test was performed; all the components from sample 1 and sample 2 passed the test.No leaks of air were found.Breathing bag from sample 3 did not pass the test, the dabc (disposable anesthesia breathing circuits) vent tube from sample 4 did not pass the leak test.The root cause was deemed to be manufacturing-related.Actions (s) taken to mitigate the reported issue(s): production personnel was re-trained on how to perform the leak test and how to read to flow meters to verify if the unit is acceptable or not; as preventive action, manufacturing personnel was notified by the quality intern as an awareness of the failure mode reported by the customer.A corrective and preventative action has been opened to address the reported issue.

Event Description

It was reported that, during pre-use checks, circuit leaks were noted.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15638410
• MDR Text Key: 306939958
• Report Number: 3012307300-2022-25364
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2020
• Device Catalogue Number: C37101678D-NL
• Device Lot Number: 3450360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1