MAUDE Adverse Event Report: NULL BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC?; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Use of Device Problem (1670)

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

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source was identified as user interface.A dhr review was unable to be performed since no lot number was provided.

Event Description

It was reported that while in use, the pilot balloon port pushed into the blue housing.Trach change done to resolve the issue.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC?
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 13359498
• MDR Text Key: 284471143
• Report Number: 3012307300-2022-01773
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White