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

Model Number 101/562/000

Device Problem Connection Problem (2900)

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

Event Date 06/26/2020

Event Type  malfunction  

Event Description

It was reported that during the pre-use test the distal portion of the device did not connect completely to the introducer.No patient injury or involvement was reported.

Manufacturer Narrative

One sample received from decontamination without its original packaging.Confirmed that no such difficulties were observed when inserted both inner cannulas into tracheostomy tube.Introducer was also smoothly inserted into tracheostomy tube when a small amount of lubricating jelly was applied as described in instruction for use (ifu).Based on above investigation and functional testing we were not able to confirm the defect reported by customer.A device history record (dhr) review was not performed as no fault was found.No information has been received to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TUBES PDT BLUPERC
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15409674
• MDR Text Key: 305721928
• Report Number: 3012307300-2022-18872
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517103397
• UDI-Public: 15019517103397
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K173912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

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 Model Number: 101/562/000
• Device Catalogue Number: 101/562/000
• Device Lot Number: 3951189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1