MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEOSTOMY; TRACHEOSTOMY BLU SELECT

Model Number 101/860/075CZ

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was not received for investigation.The customer reported issue could not be confirmed due to no receipt of photos or actual sample for investigation.Additionally, the lot number of the reported device was not provided therefore no device history review (dhr) could be performed.No root cause could be determined since no product and/or photos were received to investigate the reported issue.A material change was implemented on the new range of the reported model number however; biocompatibility was tested prior to implementation and found to be acceptable.If the product is returned at a later, a summary of the investigation results will be provided in a supplemental report.Complaint trends will continue to be monitored.D5 is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that when the patient bent his neck during the use of the product, the flange contacted to his lower jaw, where some rashes appeared.No patient harm was reported.

• Brand Name: PORTEX TRACHEOSTOMY
• Type of Device: TRACHEOSTOMY BLU SELECT
• 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; 3-21-2 motohama-cho, naka-ku,; minneapolis, MN 55442
• MDR Report Key: 15426844
• MDR Text Key: 306265394
• Report Number: 3012307300-2022-19227
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

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 Model Number: 101/860/075CZ
• Device Catalogue Number: 101/860/075CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1