MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY TUBE

Model Number	FT21DN65NSC105N
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the flange broke while in use with a patient.A trach change was done to resolve, and no adverse affects to patient were reported.
Additional Manufacturer Narrative
Corrected data: h10: incorrect regulatory contact submitted on initial.Edited to correct contact.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• MDR Report Key: 12643826
• Report Number: 3012307300-2021-10040
• Device Sequence Number: 1494923
• Product Code: JOH
• UDI-Device Identifier: 15019517265545
• UDI-Public: 15019517265545
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: No Information
• Device Model Number: FT21DN65NSC105N
• Device Lot Number: GA017658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/16/2021
• Supplement Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1