MAUDE Adverse Event Report: ICU Medical Nederland B.V. Portex BLUSelect SuctionAid Cuffed Tracheostomy Tube; Tube, tracheostomy (w/wo connector)

Catalog Number	101/563/070
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach tube was faulty and balloon constantly deflated during use with patient.Tube in-situ.Medical intervention was required.There was unknown patient harm or adverse event reported.
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 information becomes available.

• Brand Name: Portex BLUSelect SuctionAid Cuffed Tracheostomy Tube
• Common Device Name: Tube, tracheostomy (w/wo connector)
• Manufacturer (Section D): ICU Medical Nederland B.V.; bijsterhuizen 22 ¿ 08; wijchen gelderland NA 6604 LD; NL 6604 LD
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50809421
• Report Number: 3012542015-2026-00038
• Device Sequence Number: 8543196
• Product Code: BTO
• UDI-Device Identifier: 15019517103403
• UDI-Public: (01)15019517103403
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/17/2026

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: 101/563/070
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• 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