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

Catalog Number 100/856/080

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The occurrence date was reported as being (b)(6) 2018, however, notification of the complaint was received 15-mar-2018.The actual date is unknown.

Event Description

It was reported that the inner cannula of a portex® blue line ultra® tracheostomy tube was found to be a size 9 instead of a size 8.When the staff opened the package and attempted to use the tracheostomy tube, it would not fit.No injury was reported.

Manufacturer Narrative

From photographs received for evaluation, it was observed that the package indicates an 8.0 mm inner cannula and the cannula packaged was a 9.0 mm inner cannula.The most probable root causes are: the material that is returned to the transfer room, if it is not well identified, could be mixed with another material.The line clearance procedure was not properly followed.Lack of detection by production personnel in the packaging area.The following actions were taken: retraining to the production personnel was conducted by quality engineer on procedure in order to reinforce the packaging operation and the visual inspection.

• Brand Name: PORTEX® BLUE LINE ULTRA® 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
• MDR Report Key: 7419600
• MDR Text Key: 105366925
• Report Number: 3012307300-2018-01038
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 55019315052628
• UDI-Public: 55019315052628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/08/2023
• Device Catalogue Number: 100/856/080
• Device Lot Number: 3578884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 09/03/2018
• Supplement Dates FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1