MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TUBES BLUSELECT SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/860/080CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sample was received for evaluation for the complaint that the cuff does not inflate due to deformation or kinking of the pilot balloon tube.A lot history review could not be conducted because no lot number was identified.As received a kink at the inflation line pilot balloon junction was observed.In attempts to replicate clinical use the cuff was inflated using an icu medical provided syringe.The cuff inflated as normal and was observed to deflate.In attempts to visualize the source of the leak the set was submerged in a water bath.A leak was observed at the cuff.Upon further inspection a cut was observed on the cuff of the set.The complaint of leakage can be confirmed due to the cut on the cuff.The probable cause of the cut is unknown.Additionally observed a kink on the inflation line.The probable cause of the kink is unknown.
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 has been reported that the cuff does not inflate due to deformation or kinking of the pilot balloon tube.The event occurred during patient use/administration at facility.There was no reported patient harm/adverse event.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24370465
• Report Number: 3012307300-2026-01412
• Device Sequence Number: 4876686
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: (01)15019517076158
• 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,User Facility
• Initial Reporter Occupation: Other Health Care 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: 101/860/080CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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