MAUDE Adverse Event Report: BIVONA; TRACHEOSTOMY

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Event Description

Information received a smiths medical disp bivona tracheostomy tub - leaking.There was no leak observed during pre-test for two trachs.While in use, leaks were found.Xylocaine gel was used for insertion, cuffs were inflated with saline solutions.

Manufacturer Narrative

Other text: no device or photos were returned for investigation.

• Brand Name: BIVONA
• Type of Device: TRACHEOSTOMY
• MDR Report Key: 12348933
• MDR Text Key: 267503054
• Report Number: 3012307300-2021-08682
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1