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

Model Number	FT18EN50NGF061N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a customer opened new custom device and when inflating, the piece inside the pilot balloon went in and got stuck.No adverse patient effects were reported.
Additional Manufacturer Narrative
A trach change was performed to resolve the issue.The trach was returned for analysis and it could be seen that the teflon tubing used to bridge the airway line to the lumen in the shaft had worked its way inside the pilot balloon.The cuff of the returned device did inflate and deflate when air was inserted through the inflation valve, which indicates that the teflon tubing was in the correct location when the device was assembled; otherwise, the opening that joins the external airway line to the internal lumen would have been blocked by adhesive.Since no adverse trends have been identified related to this issue, no corrective actions are planned at this time.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11606707
• Report Number: 3012307300-2021-02787
• Device Sequence Number: 4216175
• Product Code: JOH
• UDI-Device Identifier: 15019517151398
• UDI-Public: 15019517151398
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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 Model Number: FT18EN50NGF061N
• Device Catalogue Number: FT18EN50NGF061N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/24/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1