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

Model Number	101/851/070
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device inserted on (b)(6) 2025 was found to be faulty.The tube cracked when a 10ml syringe was inserted, an issue that occurred multiple times recently.This required an urgent tube change and the use of device to prevent infection for the patient.There were unknown signs or symptoms experienced.
Additional Manufacturer Narrative
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 device was returned for analysis of complaint that the blue suction connector cracked.Investigation was based on photo attached to complaint.Based on the photo, issue was confirmed.The blue suction connector is cracked.Without a sample and more detailed information, unable to perform the investigation (visual inspection and testing) and determine what happened.Root cause of this defect is currently unknown - it could be a molding defect or excessive force used when connector was connected with syringe during use.No device history review (dhr) review was performed because incorrect parts and lot were recorded.There is lot number of different product.Not in relation with this complaint.

• Brand Name: PORTEX BLUSELECT REPLACEMENT INNER CANNULA
• 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: 22318989
• Report Number: 3012307300-2025-07541
• Device Sequence Number: 8819488
• Product Code: BTO
• UDI-Device Identifier: 15019517076646
• UDI-Public: (01)15019517076646(17)290530(10)6004225
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 101/851/070
• Device Catalogue Number: 101/851/070CZ
• Device Lot Number: 6004225
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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 Sex: Unknown