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

Catalog Number 100/515/090

Device Problems Air Leak (1008); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that after intubating the tracheostomy tube into the patient in the operating room, an air leak was found from the cuff.The product was no longer able to be used.No injury was reported.

Manufacturer Narrative

One blue line ultra® suctionaid tracheostomy tube was returned for analysis in a used condition.No discrepancies were noted with the product under visual examination.A leak was detected between the valve and pilot balloon when submerged under water during attempted inflation; confirming the complaint.Relevant documents were deemed adequate upon review.Cuff assembly operation was reviewed and the inflation line assembly operation was reviewed with no discrepancies.The inflation test was audited of 32 units noting the following: inconsistency in the application of thf in the nils 2 machine.Based on the evidence the complaint is confirmed.The most probable root causes of manufacturing is as follows: solvent missing between pilot balloon and valve, inconsistency in the application of thf in the nils, lack of detection by the production personnel on the leak test area.

• Brand Name: PORTEX® BLUE LINE ULTRA® 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: 7643438
• MDR Text Key: 112551794
• Report Number: 3012307300-2018-02437
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/515/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1