MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® PORTEX® BLUE LINE ULTRA® CUFFLESS TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/813/085CZ

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the connector of the cannula of a portex® portex® blue line ultra® cuffless tracheostomy tube had split in length.No adverse health outcomes.

Manufacturer Narrative

One used tracheostomy tube was returned for analysis.Visual analysis found that the tube had a 3.5cm long tear across its split line.It was also noticed that on surface of cannula there are scratches and deformations close to cannula hub and cannula tip was found to be oval.The deformations were likely the result of excessive force which was used during cleaning.The device history record was reviewed and no manufacturing or testing issues were found.Based on the evidence, the complaint was confirmed.The root cause was unable to be conclusively determined.

• Brand Name: PORTEX® PORTEX® BLUE LINE ULTRA® CUFFLESS TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7498387
• MDR Text Key: 107724034
• Report Number: 3012307300-2018-01371
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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 Expiration Date: 01/08/2023
• Device Catalogue Number: 100/813/085CZ
• Device Lot Number: 3560402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1