MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TUBES BLUSELECT SUCTIONAID; BAG, RESERVOIR

Model Number	101/870/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that staff had to inflate the cuff every hour.Due to issues with trach tube they were advised an urgent trach change.The problem was fixed by replacing the trach tube.The incident took place at patient home.The device was manipulated by a healthcare professional, there was patient involvement, there was no harm/adverse event reported.
Additional Manufacturer Narrative
Device was returned for investigation.It was reported that as received, there were no damages or anomalies observed.In order to replicate clinical use and test cuff inflation, the trach tube was filled with air using the returned syringe.The cuff was visually inspected for full inflation and air leakage.No immediate deflation was observed.An additional measure was to submerge the trach tube underwater to aid in localizing leaks.No leaks were observed.The complaint of hole in cuff cannot be confirmed nor replicated.The complaint of cuff leakage cannot be confirmed nor replicated.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: BAG, RESERVOIR
• 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: 24607582
• Report Number: 3012307300-2026-02467
• Device Sequence Number: 21226345
• Product Code: BTC
• UDI-Device Identifier: 15019517076158
• UDI-Public: (01)15019517076158(17)291022(10)6002120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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 Model Number: 101/870/070
• Device Catalogue Number: 101/860/080CZ
• Device Lot Number: 6002120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White