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

Catalog Number C1038J

Device Problem Leak/Splash (1354)

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

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

Udi and pma/(510k) are unknown; no additional information was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was not performed as no lot or serial numbers were provided.A product sample from same product number, lot number unknown, was received.Visual inspection and functional test(s) were performed.The sample was received in used conditions without its original packaging and visually inspected at a distance of 12 inches under normal lighting to received unit; no discrepancies detected.A leak test was performed and the sample did not pass.The root cause of the issue was deemed to be manufacturing-related.Action(s) taken to mitigate the reported issue(s): a corrective and preventative action has been opened to address the reported issue.

Event Description

It was reported that, immediately after opening the package, the customer performed a pre-use check of the product, and leakage of air was found at that time.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; aoba-ku, sendai-city, miyagi; minneapolis, MN 55442
• MDR Report Key: 15639057
• MDR Text Key: 306694250
• Report Number: 3012307300-2022-25381
• Device Sequence Number: 1
• Product Code: BTO
• 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: 10/20/2022

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: C1038J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/20/2022
• 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