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

Catalog Number	101/851/060CZ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach tube was found to be broken at the flange while in use with the patient.The trach tube was replaced to resolve the issue.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Received one device, visual inspection observed that the inner cannula is cracked.Investigation results indicates that it is the most probable that reported failure occurred due to excessive force used during cleaning or incorrect cleaning technique.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.
Event or Problem Description
An email was received regarding a bluselect 6.0, 101/851/060cz with lot number: 6022478.It was stated that the shirt has broken at the collar.Another internal jacket ch 6 was used to replace the one that is defective.There was involved a 39-year-old female patient weighing 97 kg with the initials (b)(6).

• Brand Name: PORTEX BLUSELECT REPLACEMENT INNER CANNULA
• 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: 21939556
• Report Number: 3012307300-2025-05088
• Device Sequence Number: 12961775
• Product Code: BTO
• UDI-Device Identifier: 15019517076639
• UDI-Public: (01)15019517076639(17)290530(10)6022478
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101/851/060CZ
• Device Lot Number: 6022478
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 97 KG