MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number FT20HN40NSE941N

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.Upon a visual inspection of the tracheostomy tube it was noticed that the distal tip of the trach was missing adhesive near the lumen.It is unclear when this damage occurred.A device history record (dhr) review could not be performed as the lot number was unknown.A thorough inspection was performed on this device and the reported issue, cuff leak, was confirmed.While attempting to inflate the cuff it could not hold any air.As previously mentioned, it was noticed that the air was escaping from distal tip of the device due to a lack of adhesive.In this particular case it seemed that some of the adhesive that was applied to secure the cuff in place had peeled off of the trach and caused an inflation defect.All cuffed products are leak-tested at two separate occasions after assembly, including one inspection at the very end of the manufacturing process.The reported problem was confirmed; however, the root cause of this event could not be determined.Complaint will be monitored to reveal any trends that may lead to further corrective actions being implemented.Udi is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during a hospital pre-test, the therapist discovered that the cuff of a custom tracheostomy tube was leaking.No patient injury was reported.

• Brand Name: BIVONA CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15458953
• MDR Text Key: 306257686
• Report Number: 3012307300-2022-19864
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2022

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: FT20HN40NSE941N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1