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

Catalog Number	101/860/070CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.B3 - date of event: the exact date of the incident is unknown, so it has been recorded as the first day of the month of awareness.
Event or Problem Description
It was reported that approximately 3.5 hours after the tube was replaced, the cuff-leak alarm activated.After extubating and immersion in normal saline, an air leak from the cuff was confirmed.The event occurred during the patient use.There was patient involvement, but no harm/adverse event reported.
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.As received no damage or anomalies were observed.In attempts to replicate clinical use the tube was inflated using an icu medical provided syringe.The cuff inflated and was observed to deflate.Upon further inspection a cut was observed in the cuff of the set.The complaint of air leakage can be confirmed due to the cut observed.The probable cause of the reported problem unknown.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL CZECH REPUBLIC A. S; olomoucká 306; 753 01 hranice ; EZ
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24551690
• Report Number: 3012307300-2026-02205
• Device Sequence Number: 20227154
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: (01)15019517076134(17)291209(10)6075599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: 101/860/070CZ
• Device Lot Number: 6075599
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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
• Patient Sex: Unknown