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

Catalog Number 100/563/090

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.The device history report (dhr) review was conducted and it was confirmed that the schematic illustration on the label was showing the cannula without subglottic suction.This kit contains a cannula with subglottic suction which was issued to the lot as per the requirements in the custom move order pick list.No product sample was received; therefore, visual and functional testing could not be performed.However a photo was attached to the complaint file which demonstrates the customers complaint.The lot was a kit which was its with blue line ultra suction aid tracheostomy tubes (as detailed in the product description on the shelf label - attached).This kit does contain a cannula with subglottic suction.The instructions for use (ifu) which was packaged with the kit also detail that the kit contains a cannula with subglottic suction.The root cause for the reported issue was confirmed in the dhr and is due to manufacturing.The label for this product was changed recently due to the labelling updates in line with the notified body.Udi information is unknown.Premarket (510k) number is unknown.

Event Description

It was reported that an incorrect cannula was placed in the package.No patient injury reported.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• 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: 15708782
• MDR Text Key: 306687144
• Report Number: 3012307300-2022-26559
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2022

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: 100/563/090
• Device Lot Number: 3665068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 11/01/2022
• 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