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

Model Number	ST16FN70NSC142N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff component of the custom tracheostomy tube failed to inflate appropriately.The patient had to go to an outpatient clinic in order to have another device placed.No further patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Two bivona tubes were returned for analysis.One trach partially inflated and the other did not inflate at all.Using a standard syringe, 14cc's of air was inserted into the inflation line ( trach #1 ), the cuff inflated evenly.Using the same syringe, 14cc's of air was inserted and the cuff did not inflate ( trach #2 ).In the second attempt, following instruction for use (ifu), the cuff inflated evenly.Per the ifu, it states under set up that if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft.Using a standard ruler, both trachs measured at 14mm on one side and 16mm on the other side of the cuff.The cuff symmetry for both devices met the manufacturing specification.The reported problem could not be confirmed.No corrective actions are planned at this time.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9392895
• Report Number: 3012307300-2019-06640
• Device Sequence Number: 2751549
• Product Code: JOH
• UDI-Device Identifier: 15019517061093
• UDI-Public: 15019517061093
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923878
• 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
• Report Date (Section B): 05/12/2020

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/16/2024
• Device Model Number: ST16FN70NSC142N
• Device Catalogue Number: ST16FN70NSC142N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 12/01/2019
• Supplement Report FDA Received Date: 05/12/2020
• 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