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

Model Number 101/860/070

Device Problem Disconnection (1171)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiration date, and device manufacture date is unknown.No product information has been provided to date.One used device was returned for investigation without its original packaging.Under visual inspection it was noticed that inflation line was detached from the pilot balloon (pilot balloon was not returned).The investigation determined this was a supplied item fault.A device history report (dhr) review could not be performed as no lot number was provided.

Event Description

It was reported that during patient use the pilot balloon got detached from the inflation line.No patient injury reported.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• 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; 7-15-26 fukushima; minneapolis, MN 55442
• MDR Report Key: 16405234
• MDR Text Key: 309862726
• Report Number: 3012307300-2023-01466
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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: 02/20/2023

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: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/20/2023
• 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