MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY TUBE

Model Number FT21DN65NSC105N

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event 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.

Manufacturer Narrative

Corrected data: h10: incorrect regulatory contact submitted on initial.Edited to correct contact.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY TUBE
• MDR Report Key: 12643826
• MDR Text Key: 276847052
• Report Number: 3012307300-2021-10040
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517265545
• UDI-Public: 15019517265545
• Combination Product (y/n): N
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT21DN65NSC105N
• Device Lot Number: GA017658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1