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

Catalog Number	101/563/090
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suctionaid tracheostomy tube taken from the size 9 bluperc kit could not maintain cuff pressure.Cuff pressure manometer observations confirmed loss of pressure while in-use with the patient.The device was returned for evaluation.
Additional Manufacturer Narrative
One device was returned for evaluation.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
D3 - manufacturing plant address 1, d3 - manufacturing plant city, d3 - manufacturing plant state, d3 - postal code, and d3 - manufacturing plant country: correction h3 and h6.Codes: updated.Device evaluation: received one (1) used bluperc percutaneous dilation procedural kit with single stage dilator and bluselect suctionaid trach tube.As received, no physical damage or other anomalies were observed.The sample was inflated with an approved icu syringe and leak tested.The sample was submerged underwater to aid in leak detection.No leaks were observed.Left the cuff inflated for 3 days, no leaks were observed.Cannot confirm customer complaint of not able to maintain cuff pressure and suspects a leak somewhere in the system.

• Brand Name: BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice MN 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23352708
• Report Number: 3012307300-2025-11635
• Device Sequence Number: 21115052
• Product Code: JOH
• UDI-Device Identifier: 15019517103427
• UDI-Public: (01)15019517103427(17)260831(10)4418887
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 101/563/090
• Device Lot Number: 4418887
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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