MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CONTINUOUS CAUDAL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/594/000

Device Problem Fitting Problem (2183)

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

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Functional testing was performed.Functional testing found the edge of the product did not reach the limits for luer tape test after applying 3.5 kg force.Further investigation shows that the female /male taper test was inadequate/incorrect, since images of how to determine a correct or incorrect component were inadequate and could cause an incorrect interpretation of results.The root cause of the reported issue was found to be related to a supplier issue since the defective component is a component provided by the supplier site.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).Operator of device is unknown.(udi) and pma/510k are unknown.No information is provided to date.

Event Description

It was reported that during a pre-use check, the customer attempted to connect the product with a tracheostomy tube, but it was so tight that it could not be securely fixed.No patient injury was reported.

• Brand Name: PORTEX CONTINUOUS CAUDAL
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16632540
• MDR Text Key: 312412988
• Report Number: 3012307300-2023-03142
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 100/594/000
• Device Lot Number: 3786881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1