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

Catalog Number	100/856/080
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7419600
• Report Number: 3012307300-2018-01038
• Device Sequence Number: 16537911
• Product Code: BTO
• UDI-Device Identifier: 55019315052628
• UDI-Public: 55019315052628
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1