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

Model Number	ST14EN75TSC280N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the custom bivona tracheostomy failed to hold air during placement.An emergent tracheostomy change was performed on the patient.No serious injury was reported in connection with this incident.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
One customized fixed 7.5mm id device was returned for evaluation.The product cuffs (stoma and distal cuffs) were inflated and leak tested , and during a leak test bath.No leaks were found.The dhr was reviewed for the lot number provided.One device was manufactured for this lot and there were no non-conformities or abnormalities during manufacturing or quality inspection.Per the dhr review, the device passed qa inspection.

• Brand Name: BIVONA® TRACHEOSTOMY TUBE CUSTOMIZATION SERVICES
• 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: 7466730
• Report Number: 3012307300-2018-01247
• Device Sequence Number: 144940
• Product Code: JOH
• UDI-Device Identifier: 10351688787217
• UDI-Public: 10351688787217
• 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: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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?: No
• Operator of Device: No Information
• Device Expiration Date: 01/25/2018
• Device Model Number: ST14EN75TSC280N
• Device Catalogue Number: DS013011
• Device Lot Number: DS013011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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