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

Model Number 101/870/070CZ

Device Problem Misassembly by Users (3133)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

Situation described in complaint description is clearly user failure.Instruction for use (change of tube section) provides sufficient information that obturator shall be removed once tracheostomy tube is inserted: "insert the tracheostomy tube in accordance with currently accepted medical or surgical techniques and remove the obturator." manufacturing device history record review was not performed - user issue.

Event Description

It was reported that the customer was taking out the product (tube) from the patient for regular replacement, and forgot to remove the obturator from the patient, which prevented the customer from performing respiratory ventilation on a temporary basis.No patient injury was reported.

• Brand Name: PORTEX BLUSELECT DILATION TRACHESTOMY KIT
• Type of Device: TUBE, TRACHEAL (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: 14928513
• MDR Text Key: 295340492
• Report Number: 3012307300-2022-12912
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076202
• UDI-Public: 15019517076202
• 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
• Report Date: 07/06/2022

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: 101/870/070CZ
• Device Catalogue Number: 101/870/070CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1