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

Catalog Number	101/860/075CZ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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.
Event or Problem Description
It was reported that the cuff was broken.The event occurred during the patient use.There was no adverse event.
Additional Manufacturer Narrative
Neither sample nor pictures were received for the analysis of this complaint.No device history record was reviewed as the lot number was not provided.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.
Additional Manufacturer Narrative
H3/h6: one used device was returned for evaluation.The device was visually inspected.The inflation line was observed to be cut in two.Further inspection of the cut tubing showed textured inner and outer lining.Additionally observed a tear in the cuff of the set.The deformation showed multiple angles in the tear.Further inspection of the cut tubing showed textured inner and outer lining.Additionally observed a tear in the cuff of the set.The deformation showed multiple angles in the tear.The complaint of broken cuff can be confirmed due to the tear observed on the cuff.The probable cause of the tear in the cuff is unknown.During inspection a cut inflation line was observed.The probable cause of the cut is unknown.No device history record was reviewed since lot number was not provided.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY
• 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: 23817435
• Report Number: 3012307300-2025-13519
• Device Sequence Number: 9350409
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: (01)15019517076141
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 101/860/075CZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/16/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/29/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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