MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBE

Model Number	FT20DN50NSF069N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical trach tube leaked h2o from cuff causing cuff to deflate.Trach change was needed.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: additional information: d10, h6, h10: device evaluation: one smiths medical smiths medical trach tube was returned for analysis.During analysis, using leak test procedure air was applied to the device and a leak detected on pilot balloon.Using magnification, a cut/hole was found while manipulating the pilot balloon.All devices are 100% leak tested prior to packaging.The instruction for use states under warnings to guard against product damage by avoiding contact with sharp edges.The investigation did not reveal any intrinsic manufacturing defects with the returned device.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be user interface.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10624899
• Report Number: 3012307300-2020-09892
• Device Sequence Number: 2604205
• Product Code: JOH
• UDI-Device Identifier: 15019517226164
• UDI-Public: 15019517226164
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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 Expiration Date: 04/30/2025
• Device Model Number: FT20DN50NSF069N
• Device Catalogue Number: FT20DN50NSF069N
• Device Lot Number: BS006496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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