MAUDE Adverse Event Report: ICU MEDICAL CZECH REPUBLIC A. S PORTEX BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/563/080
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that since the change in the design of the dilator, tracheostomies have developed significant leaks in the days after insertion, necessitating a return to theatre for surgical tracheostomy insertion.It was also stated that the end of the tracheostomy was abutting the anterior wall.There was patient involvement.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: neither sample nor pictures were received for the analysis of this complaint.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was provided.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 24925817
• Report Number: 3012307300-2026-03962
• Device Sequence Number: 5357076
• Product Code: JOH
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173912
• 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): 04/20/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 101/563/080
• Device Lot Number: UNKNOWN
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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