MAUDE Adverse Event Report: NULL BIVONA ADULT TTS TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number BRC285

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was unable to be performed as no lot information was provided.

Event Description

It was reported that the issue with the tracheostomy was that it was not fenestrated, so windows were created using the atos fenestration punch in one of the internal cannulas and the external cannula.Unfortunately, the inner cannula was very soft and weakened due to the windows, making it impossible to insert.There was no additional information provided.

• Brand Name: BIVONA ADULT TTS TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section G): NULL
• MDR Report Key: 14014105
• MDR Text Key: 288601839
• Report Number: 3012307300-2022-05830
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2022

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
• Device Catalogue Number: BRC285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR