MAUDE Adverse Event Report: ICU MEDICAL CZECH REPUBLIC A. S PORTEX TUBES BLUSELECT SUCTIONAID; BAG, RESERVOIR

Catalog Number	100/870/080CZ
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 stated that during the surgical tracheostomy procedure, the cuff balloon ruptured in two cannulas successively, without any perceptible cause.The event was detected during clinical use, and the customer classified the incident as a rupture.There was no patient harm.
Additional Manufacturer Narrative
Three images were provided by the customer showing two trach tubes with ruptured cuffs.The complaint of cuff damage can be confirmed based on the returned images.The probable cause is unknown.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.A device history review was performed and found no non-conformances.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• Manufacturer (Section D): ICU MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24014928
• Report Number: 3012307300-2026-00232
• Device Sequence Number: 15737415
• Product Code: BTC
• UDI-Device Identifier: 15019315104862
• UDI-Public: (01)15019315104862(17)290715(10)6016300
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: UNKNOWN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 100/870/080CZ
• Device Lot Number: 6016300
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/11/2026
• 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
• Patient Sex: Unknown