MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUE LINE CLASSIC; TRACHEOSTOMY TUBE AND TUBE CUFF.

Model Number 100/506/045

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Kinesiologist reports that after 24 days of use cannula separated from the body of the collar.It was realized and the mother managed to change it very carefully before it completely detached itself and got stuck in the windpipe.The patient suffered no major complications since it was caught.

Manufacturer Narrative

Two photos were returned for investigation.Upon inspection, it was found that the complained issue could be verified with the most probable root cause from an incomplete weld in manufacturing process.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PORTEX TUBES BLUE LINE CLASSIC
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF.
• 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: 11580201
• MDR Text Key: 242668306
• Report Number: 3012307300-2021-02548
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100/506/045
• Device Catalogue Number: 100/506/045
• Device Lot Number: 3814893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male