MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TIGHT TO SHAFT (TTS) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	670185
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the trach tube was purchased on (b)(6) 2022 and it was used once.The customer cleaned it and then tested the balloon.The balloon was hard to inflate.They did not reinsert this trach but opened up a new box and reinserted a new trach.There has been no report of patient injury, no observable clinical symptoms, or a change in symptoms identified in the patient as a result of this product malfunction.
Additional Manufacturer Narrative
D10 - device available for evaluation, h3 - device evaluated by manufacturer, h6 - evaluation codes: updated device evaluation: one device in used condition, without its original packaging, for investigation.There were no unusual conditions detected in relation to cuff inflation or deflation.Functional testing could not confirm the reported complaint; no root cause could be established.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.As no fault was found, no actions taken at this time.Complaints will continue to be monitored.

• Brand Name: BIVONA TIGHT TO SHAFT (TTS) TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 112; minneapolis, MN 55442
• MDR Report Key: 16541550
• Report Number: 3012307300-2023-02432
• Device Sequence Number: 14993735
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: Other
• Device Expiration Date: 04/26/2026
• Device Model Number: 670185
• Device Catalogue Number: 670185
• Device Lot Number: 4137671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown