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

Model Number	FT18GN35NGF032N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation results: one custom bivona tracheostomy tube was returned for investigation in used condition.Using a syringe, 5 cc of air was inserted into the inflation valve.The cuff inflated, but quickly deflated.A leak test was performed.A leak was detected in the airway line below the inflation balloon.The source of the leak was a cut in the airway line.Custom devices are 200% inspected for leaks and cuff symmetry, which require the cuff to remain inflated.If the cut was present at the manufacturing site, the device would not have passed inspection.The investigation did not identify a manufacturing defect.The instructions for use (ifu) instructs the user to guard against product damage by avoiding contact with sharp edges.The product came into contact with a sharp edge.This was identified as the root cause of the issue.
Event or Problem Description
It was reported that the pilot balloon of the bivona tracheostomy tube was leaking.The tracheostomy tube had to be changed out as a result.No patient injury or complications were reported in relation to this event.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL, ASD INC.; 6000 nathan lane; minneapolis, mn
• MDR Report Key: 10379662
• Report Number: 3012307300-2020-06850
• Device Sequence Number: 2898408
• Product Code: JOH
• UDI-Device Identifier: 15019517157697
• UDI-Public: 15019517157697
• 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
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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 Model Number: FT18GN35NGF032N
• Device Catalogue Number: FT18GN35NGF032N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/07/2020
• 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