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

Catalog Number	100/815/080
Medical Device Problem Code	Human Factors Issue (2948)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the patient developed a stage 3 pressure sore at the site of a portex® blue line ultra® tracheostomy tube.It was noted that the flange on the device does not contain any gel like or other soft barrier to help prevent pressure injuries.The tracheostomy tube requires use of other materials such as gauze or gel pads to decrease/eliminate pressure.No permanent injury was reported.

• 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: 6764961
• Report Number: 3012307300-2017-01676
• Device Sequence Number: 1967588
• Product Code: BTO
• UDI-Device Identifier: 15019315045387
• UDI-Public: 15019315045387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: No Information
• Device Catalogue Number: 100/815/080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2017
• 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: Other
• Patient Age: 59 YR