MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE (3.5 TTS FLEXTEND 1A); TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT18DN35NGF006N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the custom silicone bivona tracheostomy tube was placed at 7 a.M., by 3 p.M., the tracheostomy tube had leaked by a value of 20%.No death or serious injury was reported in connection with this incident.

• Brand Name: BIVONA TRACHEOSTOMY TUBE (3.5 TTS FLEXTEND 1A)
• 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: 7891746
• Report Number: 3012307300-2018-03744
• Device Sequence Number: 2508162
• Product Code: JOH
• UDI-Device Identifier: 15019517146264
• UDI-Public: 15019517146264
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/19/2018

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 Expiration Date: 08/15/2023
• Device Catalogue Number: FT18DN35NGF006N
• Device Lot Number: DS019242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1