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

Catalog Number	101/870/080CZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff did not inflate.The event occurred during the patient use.There was no adverse event.
Additional Manufacturer Narrative
One device was received for evaluation.As received a tear was observed on the cuff of the set.The deformation of the tear was observed to be uneven with multiple pieces.The complaint of non-inflation can be confirmed due to the observed tear.Due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure due to over pressurization.

• 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; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24046615
• Report Number: 3012307300-2026-00286
• Device Sequence Number: 9348606
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: (01)15019517076226(17)291023(10)6008362
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 101/870/080CZ
• Device Lot Number: 6008362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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