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

Catalog Number 100/517/080

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

One used portex® blue line ultra® cuffed tracheostomy tube was returned for investigation.The sample was visually inspected and no holes were detected in the cuff or the pilot balloon.Use testing revealed leakage coming out of the pilot balloon.A manufacturing review of a similar device was performed and no discrepancies were found in the manufactured samples.The most probable root cause was determined to be a manufacturing issue.The machine used in the manufacture of the device has movement and is not stable, and the pilot balloon is raised from the valve area because the pilot balloon does not enter completely in the fixture, which could cause the valve to touch the pad and cause the tear.

Event Description

It was reported that after intubating the patient with a portex® blue line ultra® cuffed tracheostomy tube, an air leak occurred from the cuff.The fault was discovered after the artificial respirator alarmed.After removing the product from the patient, the user injected air into the cuff of the tube and found bubbles.No injury was reported.

• Brand Name: PORTEX® BLUE LINE ULTRA® CUFFED 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: 7313063
• MDR Text Key: 101500289
• Report Number: 3012307300-2018-00471
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

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: No Information
• Device Catalogue Number: 100/517/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1