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

Catalog Number	100/541/080CZ
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the blue line ultra percutaneous tracheostomy balloon was perforated.In a test performed on the cannula, it was confirmed the leakage was from the cuff.No death or serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One tracheostomy tube was returned for analysis.Visual inspection performed and product appeared to be in good condition.Customer's complaint was verified.Leakage test was initially performed and the cuff leaked so badly the cuff could not be inflated.Air observed to be leaking from a 1 millimeter tear in the cuff.Most likely the tear occurred due to contact with sharp edge or sharp tool.Trending was reviewed for the last two years of customer complaints with no trends.The true problem source is unknown.

• Brand Name: BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY
• 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: 7703769
• Report Number: 3012307300-2018-02796
• Device Sequence Number: 600857
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 04/24/2022
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: 3372865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1