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

Catalog Number	855190
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bivona fome-cuf tracheostomy leaked at the cuff after 5 days in use.No adverse patient effects were reported.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• 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: 9194209
• Report Number: 3012307300-2019-05513
• Device Sequence Number: 1879133
• Product Code: JOH
• UDI-Device Identifier: 15021312006926
• UDI-Public: 15021312006926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K912469
• 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): 10/15/2019

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: Health Professional
• Device Catalogue Number: 855190
• Device Lot Number: 263134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1