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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the tracheostomy procedure it was observed by the doctor that the cuff was not inflating adequately.The device was not in use after incidence.The event occurred at hospital during use.The operator of the device was healthcare professional.There was 1 quantity affected.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: 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.
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that during the tracheostomy procedure it was observed by the doctor that the cuff was not inflating adequately.There was not raised any other customer complaint against reported lot number.As received no damage or anomalies were observed.In attempts to replicate clinical use the cuff was inflated using a syringe provided by icu medical.The cuff was observed to inflate and then deflate.In attempts to visualize any leakage the set was submerged in a water bath and inflation was reattempted.Leakage was observed from the cuff.Upon further inspection a shaped tear/cut was observed.The complaint of cuff not inflating can be confirmed due to the observed tear/cut.The probable cause of the tear is unknown.

• 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: 23606967
• Report Number: 3012307300-2025-12711
• Device Sequence Number: 9249417
• Product Code: JOH
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)270811(10)6030577
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 101/563/080
• Device Lot Number: 6030577
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/27/2026
• 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