MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/080
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This device is same and/or similar to a device approved for distribution in the us.
Event or Problem Description
It was reported that a portex® uniperc® adjustable flange extended-length tracheostomy tube was unable to be secured in place.The tracheostomy tube had been in use for 11 days and the flange locking device was working until the date of the event.The patient was stable at the time of the event.The tracheostomy tube was replaced upon noticing the fault.No permanent injury was reported.
Additional Manufacturer Narrative
One used tracheostomy tube was received for investigation.Upon visual inspection, it was observed that the blue locking clamp was not assembled correctly with the flange, resulting in an inability to fix the flange with the tube.The device was then disassembled and reassembled correctly, and the flange was able to be fixed to the tube.Due to fact that product was in use several days without any problem, the most probable root cause is that the blue locking clamp was disassembled from adjustable flange during use by user (it is not allowed in ifu) and then incorrectly assembled.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH 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: 7252501
• Report Number: 3012307300-2018-00220
• Device Sequence Number: 13692502
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 100/897/080
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention