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

Model Number	67P035
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided.
Event or Problem Description
Information was received indicating that the bivona tracheostomy tube had be changed.It was reported that the ventilator alarmed and during trouble shooting the tube decannulated.When the syringe was removed the cuff deflated.There was no patient injury reported.
Additional Manufacturer Narrative
Other text: concomitant medical products: additional information was received stating ventilator used in incident as concomitant device is not a smiths medical device.
Additional Manufacturer Narrative
Other, other text: device evaluation- the device was returned for evaluation.The visual examination showed the device was missing the pilot valve.The valve being missing would allow cuff to deflate and prevent cuff from being filled.It was determined the valve was likely present at one time (in order for initial cuff inflation to have been performed).The issue was determined likely to have occurred during use.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10582842
• Report Number: 3012307300-2020-09783
• Device Sequence Number: 11072985
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020

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: Health Professional
• Device Model Number: 67P035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 11/01/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 09/29/2020; 11/30/2020
• 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