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

Catalog Number 100/515/080

Device Problem Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the event occurred in "(b)(6)" 2017.The exact date is unknown.(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that the air pressure of the cuff of a portex® suctionaid® tracheostomy tube was unable to be raised, even after filling air in the product through the inflation line.No injury was reported.

Manufacturer Narrative

One tracheostomy tube was returned for analysis in unused condition without the original packaging.Visual examination of the tube found a tear in the cuff.No other holes were detected.Functional testing included inflation testing.A syringe was used to inflate the cuff of the tube.The tube was then submerged under water to detect any leaks.Bubbles were noted and a leak was found.Based on the evidence, the complaint was confirmed.The root cause was unable to be determined.

• Brand Name: PORTEX® SUCTIONAID® 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: 7332073
• MDR Text Key: 102213976
• Report Number: 3012307300-2018-00398
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 04/29/2018
• Supplement Dates FDA Received: 05/24/2018
• 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