MAUDE Adverse Event Report: NULL; TRACHEOSTOMY TUBE

Device Problem Leak/Splash (1354)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

During an urgent trach tube exchange, the clinician placed a 3.0 bivona tts flextend trach and discovered the cuff was defective and not holding water.Subsequently, a 3.0 bivona tts (non-flextend) was placed and also had a defective cuff, and was not holding water.This is 3rd out of 3 reference for (b)(4) for related complaints and attachments.This is to document the 3rd device, an urgent trach change that was originally being treated.No patient serious injury was reported.

• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 13167860
• MDR Text Key: 285532002
• Report Number: 3012307300-2022-00093
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/05/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 5 KG