MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD.; TRACHEOSTOMY TUBE

Model Number 100/150/070

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that an endotracheal tube is not suitable for long term ventilated patients as it bends and or kinks easily restricting gas flow to and from a patient.Packaging is not clearly identified.No adverse patient effects were reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.One unused tracheal tube was received for analysis.This device was forwarded to the supplier from whom these components are sources, along with details of this complaint.The supplier report indicates that no manufacturing-related issues were observed during their analysis.Measurements of the tube's inner and outer diameters found them within specification, per their report, and no issues were found during batch production or inspections records reviews.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.

• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 12808271
• MDR Text Key: 280770378
• Report Number: 3012307300-2021-11193
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/150/070
• Device Catalogue Number: 100/150/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1