MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC BIVONA TUBES CUSTOM TUBES

Model Number	ST19CN50NGF059N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bivona custom tracheotomy tube was leaking.The patient experienced symptoms such as gargling and chocking.An emergent trach change was performed as a result.
Additional Manufacturer Narrative
One smiths medical custom 5.0mm id fixed tracheostomy tube with a tts cuff was returned for evaluation.Device underwent functional testing to detect for leakage.A leak was confirmed to be coming from the inside of the tube where the airway/teflon enters the tube.Further investigation noted the teflon had punctured through wall of the tube,and by moving the airway line back-and-forth the air slowly decreased.The reported complaint has been confirmed, and the problem source has been determined to be due to manufacturing.

• Brand Name: BIVONA TUBES CUSTOM TUBES
• Common Device Name: BIVONA TUBES CUSTOM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8634216
• Report Number: 3012307300-2019-03680
• Device Sequence Number: 1858263
• Product Code: JOH
• UDI-Device Identifier: 15019517185966
• UDI-Public: 15019517185966
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 150195171859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/26/2024
• Device Model Number: ST19CN50NGF059N
• Device Catalogue Number: ST19CN50NGF059N
• Device Lot Number: DS025635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1