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

Catalog Number C49101320J

Device Problem Leak/Splash (1354)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(udi) and (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).No lot number was provided; therefore, a device history record (dhr) review could not be completed.The sample was received in used conditions without its original packaging.Visual inspection: the sample was visually inspected at a distance of 12 inches under normal lighting; there was a tear on the tube.Functional test: a leak test was performed; the breathing circuit did not pass the test.The most probable 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, after establishing a connection of the product and when performing a pre-use air leak check on it, air leaked from the part where a scotch tape was affixed.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: 15650456
• MDR Text Key: 306893279
• Report Number: 3012307300-2022-25682
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2022

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: C49101320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/21/2022
• 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