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

Model Number	9.0 MM
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Airway Obstruction (1699)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|silicone: bivona tubes adult aire-cuff was leaking.The report indicated ongoing issues with cuff leaking with multiple factors and not exclusive to the fault of tub.The cuff was reported to be inspected and checked prior to insertion.Medical intervention of a tracheostomy change out was done.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11645629
• Report Number: 3012307300-2021-03010
• Device Sequence Number: 2987956
• Product Code: JOH
• UDI-Device Identifier: 15021312006490
• UDI-Public: 15021312006490
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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 Model Number: 9.0 MM
• Device Catalogue Number: 755190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1