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

Model Number	101/815/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they installed in the operating room a first blu select tracheostomy tube and inflated the cuff.Within 24 hours they had installed 2 of these tubes (one on july 16 and another on july 17).Both were leaking and they could not keep the pressure and have a perfect seal into the patient's trachea.They had to install a third tube (an old portex dic tube) to be able to keep a good seal and without having to re-inflate the cuff continuously.All these procedures in the first 24 hours, needed a lot from all the clinical staff and they had to administered benzodiazepin to the patient.
Additional Manufacturer Narrative
No product returned for investigation.

• Brand Name: PORTEX TUBES BLUSELECT
• Common Device Name: 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; bureau 117-c; minneapolis, MN 55442
• MDR Report Key: 13472143
• Report Number: 3012307300-2022-02786
• Device Sequence Number: 4690380
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: 15019517077360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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 Expiration Date: 09/16/2025
• Device Model Number: 101/815/080
• Device Catalogue Number: 101/815/080
• Device Lot Number: 4021055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown