MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUSELECT DILATION TRACHESTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/870/060CZ

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Event Description

It was reported that fourteen (14) days after the customer started to use the product, the inflation line became detached from the pilot balloon.No patient injury was reported.

Manufacturer Narrative

Other, other text: manufacturing device history record review was not performed because it is a supplier design issue.A product sample was received for evaluation.Visual inspection was performed.Visual inspection found the inflation line was detached from pilot balloon.The root cause of the reported issue was found to be the supplier design.This issue was escalated to an internal capa and the occurrence is being monitored via the tnd corrective action.

• Brand Name: PORTEX BLUSELECT DILATION TRACHESTOMY KIT
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15001145
• MDR Text Key: 304448223
• Report Number: 3012307300-2022-13296
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076196
• UDI-Public: 15019517076196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Model Number: 101/870/060CZ
• Device Catalogue Number: 101/870/060CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1