MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TTS TRACHEOSTOMY TUBE ADULT TIGHT TO SHAFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 670180

Device Problem Leak/Splash (1354)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Other operator of device: operator of device is unknown.Initial reporter occupation: product specialist investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the tracheostomy tube was placed and leaked after 16 days of use.A second tube was placed and leaked after 2 days of use.As a result, a third tube was placed.There was patient involvement and no patient harm/adverse event reported.This complaint was created to capture the 1st of 2 related incidents.

Manufacturer Narrative

Updated.Device evaluation: two used devices were returned for investigation.During visual inspection no defects were detected in the sample.Functional testing found the samples were inflated with the use of a syringe and submerged under water to detect the reported condition.A leak in the cuff was identified; complaint was confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: BIVONA TTS TRACHEOSTOMY TUBE ADULT TIGHT TO SHAFT
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18702379
• MDR Text Key: 335352815
• Report Number: 1824231-2024-00009
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K083641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 670180
• Device Lot Number: 4335532
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention