MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PVC - PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/860/085CZ
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction channel of the tracheostomy tube does not work properly, and the secretions cannot be removed by syringe or with suction.Slightly adjusting the position of the cannula corrects the situation little, but using saline or flushing the tube with air does not help at all.Several patients have had the same problem since the summer and changing the cannulas will not change the situation.There was patient involvement, but no injury.
Additional Manufacturer Narrative
B3: event date unknown.Device evaluation: one used decontaminated sample was received in plastic bag without its original packaging.Device was visually inspected.No obstruction, damage nor deformation was observed.To verify if there is any problem with connection we replicated connection with a spare syringe and vacuum control valve which are part of affected tracheostomy kit.No issue was observed, components were easily connected with suction connector, no disconnection observed.Based on above testing we did not identify any problem with returned device.No trend of similar customer complaints was identified.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21141670
• Report Number: 3011237704-2025-00009
• Device Sequence Number: 13077051
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: (01)15019517076165(17)280310(10)4382005
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 101/860/085CZ
• Device Lot Number: 4382005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown