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

Catalog Number 100/860/075

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the event occurred in (b)(6) 2018.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 during use of the tracheostomy tube, the user attempted to draw "bodily secretion" through the cuff's upper suction line, but was unable to.No injury was reported.

Manufacturer Narrative

One smiths medical portex® blue line ultra® suctioned tracheostomy tube was returned for analysis in used condition.No discrepancies were found upon visual examination.A syringe was used to pass ink through the suction line to check for occlusions.The ink passed through the line not confirming the complaint.Relevant documents were reviewed and deemed adequate.A review of the manufacturing process was conducted.Operations were reviewed with no discrepancies found: the line clearance record of the line; training records of the operators that performs the crop eye in suction line; training records of the operators that performs the bonding operation of the suction line; suction line bonding operation was reviewed; crop eye in suction line operation was reviewed.The flow test was audited during thirty two (32) units with no occlusions were detected.Based on the evidence no root cause has been determined since the complaint was not confirmed.

• 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: 7527298
• MDR Text Key: 108791228
• Report Number: 3012307300-2018-01548
• 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: 07/13/2018

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 Expiration Date: 11/02/2022
• Device Catalogue Number: 100/860/075
• Device Lot Number: 3529813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1