MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL BIVONA CUSTOM TRACHEOSTOMY TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	FT15EN35NGF192S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that after a couple weeks in use, a smiths medical bivona custom tracheostomy tube had a leak in the cuff.No adverse effects reported.

• Brand Name: SMITHS MEDICAL BIVONA CUSTOM TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9763770
• Report Number: 3012307300-2020-01586
• Device Sequence Number: 618979
• Product Code: BTR
• UDI-Device Identifier: 15019517195712
• UDI-Public: 15019517195712
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: No Information
• Device Model Number: FT15EN35NGF192S
• Device Catalogue Number: FT15EN35NGF192S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1