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

Model Number	670190
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when a cannula was inserted into the patient after initial preparation according to the manufacturer's instructions.During the attempt to fill the tts cuff with water, a small hole was found in the pilot balloon.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: additional information from customer.The small hole was found to be tight when checking the cuff with aua.
Additional Manufacturer Narrative
Device evaluation: one device was returned for analysis in used condition without its original packaging.Functional testing involved leak testing.During the test, a leak was found in the pilot balloon confirming the complaint.The investigation determined that the cut was created during molding process and the cut was not located in the partition lines or in the join between the pilot balloon and the line.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the investigation determined the most probable, but unconfirmed cause, to be that damaged occurred after the product left smiths medical facilities.

• 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: 11118557
• Report Number: 3012307300-2021-00075
• Device Sequence Number: 14351470
• Product Code: JOH
• UDI-Device Identifier: 15021312006094
• UDI-Public: 15021312006094
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

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: Health Professional
• Device Expiration Date: 02/04/2025
• Device Model Number: 670190
• Device Catalogue Number: 670190
• Device Lot Number: 3926896
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 03/11/2021; 06/11/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/08/2021; 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1