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

Model Number FT15JN35NGF889N

Device Problem Leak/Splash (1354)

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

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.The returned device was examined and a functional failure of the tracheostomy tube was noted.A leak defect was not able to be replicated; however, an inflation defect was identified.Neither air nor sterile water could pass through the airway.There was resistance from the pilot balloon and rather than the air or water traveling to the cuff it remained in the balloon.A device history record (dhr) review was performed and found no instances of non-conformities, scrap, or rework that could be related to the customer's issue.The root cause of the failure identified was unable to be determined.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that the nurse opened the box, tested for a tracheostomy cuff leak and found that the water traveled into the cuff and down the shaft.This event occurred during pre-test of the device.No patient injury was reported.

• Brand Name: CUSTOM FLEXTEND TTS TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15443266
• MDR Text Key: 305889439
• Report Number: 3012307300-2022-19565
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517026573
• UDI-Public: 15019517026573
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2022

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 Expiration Date: 06/05/2024
• Device Model Number: FT15JN35NGF889N
• Device Catalogue Number: FT15JN35NGF889N
• Device Lot Number: SS022104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 09/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1