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	07/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device returned for investigation.
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 device returned for investigation.
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.

• 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: 13471758
• Report Number: 3012307300-2022-02781
• Device Sequence Number: 3886771
• 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