MAUDE Adverse Event Report:; TRACHEOSTOMY TUBE

Model Number BTO

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that customer states that her son received 2 new trachs in (b)(6) of 2020.The angle of the new trachs were off by "quite a bit" so the tubes didn't fit in the trachea properly and protrude by about a 1/2 inch.Customer is returning one of the defective tubes with a correct tube for reference.The second wrong tube is being used to maintain patient airway at the moment.No adverse patient effects were reported.

Manufacturer Narrative

Two bivona tracheostomy tube was returned for the evaluation of the reported issue.Based on details in the description, the complaint device was identified from the preferred device.A picture showing both labeled devices was sent to the complainant for confirmation.The devices were accurately identified.Placing the complaint sample on the manufacturing drawing showed that the curve aligned exactly.The complaint device was determined to have been manufactured to the template.Placing the preferred device on the drawing showed that the curve was more relaxed.The age, usage and cleaning history of the preferred device is unknown.To address the complainant's preference, drawing, zu21cn60nsb099, and rod were created from returned preferred sample.If the complainant, wants to order a device similar to the preferred device, a new template will need to be provided with the updated curve of 95 degrees.No fault was found and customer's complaint was unconfirmed.Using customer details provided in the complaint, the part number was determined to be zu17gn60nsb094s and the lot number was determined to be bs011464.

• Type of Device: TRACHEOSTOMY TUBE
• MDR Report Key: 11458136
• MDR Text Key: 240610366
• Report Number: 3012307300-2021-01903
• 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
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BTO
• Device Lot Number: BS011464
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• 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: Initial
• Patient Sequence Number: 1