MAUDE Adverse Event Report: NULL; TRACHEOSTOMY TUBE

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

It was reported that post procedure a nurse noted that sterile water was still in the pilot balloon.The cuff was deflated.Trach was not holding 1.4 ml of water.No adverse patient effects were reported.

• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 12808257
• MDR Text Key: 280769676
• Report Number: 3012307300-2021-11188
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 11/13/2021
• 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
• Patient Sequence Number: 1