MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX

Model Number 101/860/080CZ

Device Problem Decrease in Pressure (1490)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that the product (a tracheostomy tube) worked properly for a while.However, one (1) week after starting to use it, the customer noticed air pressure of the cuff began to lower.So the customer removed the product from the patient and he noticed the inflation line was detached from the product.No patient injury.

Manufacturer Narrative

Device evaluation - one tracheostomy tube was received for evaluation in relation to the reported event.Visual inspection was able to confirm the reported event.Visual inspection noticed that inflation line was detached from pilot balloon.Root cause was unable to be determined due to the nature of the reported issue.A dhr review was unable to be completed as no lot information was provided.

• Brand Name: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12862178
• MDR Text Key: 281154318
• Report Number: 3012307300-2021-11738
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1