MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY TUBE AND TUBE CUFF

Model Number	ST19EN55NGG996N
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One smiths medical tracheostomy|silicone - bivona tubes custom was returned for analysis.During analysis, it was confirmed that the product leaked, and there were markings on the exterior airway tubing, which is where the air was leaking out of.Presumably, markings noted on the airway tubing were from the customer's teeth.The customers complaint also alleges an issue where the "inflation line" would keep falling out after filling the cuff with water or removing water from it.Presumably, this is in reference to the valve.The valve of the returned sample was reviewed and found to be in the correct position.Upon inflating/deflating the tube, there were no issues noted where anything became separated.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be user interface.
Event or Problem Description
Information was received indicating that while in use of a smiths medical tracheostomy|silicone - bivona tubes custom, the trach kept coming falling out.It was also reported that the patient was trying to reinsert the inflation line after it had come out.To reinsert the inflation line, the patient was using their teeth to stabilize the pilot balloon and ended up biting through the pilot balloon.Subsequently, trach change out was performed.No further adverse effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• MDR Report Key: 12490671
• Report Number: 3012307300-2021-09437
• Device Sequence Number: 19841188
• Product Code: JOH
• UDI-Device Identifier: 15019517190663
• UDI-Public: 15019517190663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: ST19EN55NGG996N
• Device Catalogue Number: ST19EN55NGG996N
• Device Lot Number: SS022168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR