MAUDE Adverse Event Report:; TRACHEOSTOMY TUBE AND TUBE CUFF

Device Problems Gas/Air Leak (2946); Material Deformation (2976)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that the device was deformed and leaking air.This was during testing.No patient injury.

Manufacturer Narrative

Corrected data: product code and common device name were added.

• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• MDR Report Key: 12354549
• MDR Text Key: 270274598
• Report Number: 3012307300-2021-08761
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

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: No Information
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/08/2021
• 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: N
• Patient Sequence Number: 1