MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX BLUSELECT CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/800/060CZ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient did not pull the tube who was observed 24 hours a day.The tube was inserted one day prior to breakage.The patient was on overnight ventilation.There was a medical intervention required, and emergency tube was changed.The event was resolved, and there was no patient harm.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).H3, h6: 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 information becomes available.
Additional Manufacturer Narrative
No testing was performed because no sample was provided.One photo was provided, and visual inspection confirmed the reported issue.The flange of the tracheostomy tube appeared to be cracked.Without a sample and more detailed information, an exact cause could not be determined.The cause of the reported issue is unknown.A review of the device history records shows there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX BLUSELECT CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22464823
• Report Number: 3012307300-2025-08147
• Device Sequence Number: 14521123
• Product Code: BTO
• UDI-Device Identifier: 15019517076066
• UDI-Public: (01)15019517076066(17)290520(10)6004296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 101/800/060CZ
• Device Lot Number: 6004296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: 10 YR
• Patient Sex: Unknown
• Patient Weight: 28 KG
• Patient Race: White