MAUDE Adverse Event Report: ICU Medical Nederland B.V. Portex Tubes BLUselect Suctionaid; Tube, Tracheostomy (W/Wo Connector)

Catalog Number	101/811/080CZ
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Portex Tubes BLUselect Suctionaid
• 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: 50098614
• Report Number: 2025816-2026-00098
• Device Sequence Number: 16020146
• Product Code: BTO
• UDI-Device Identifier: 15019517076370
• UDI-Public: (01)15019517076370(17)301124(10)6156902
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: Other
• Device Catalogue Number: 101/811/080CZ
• Device Lot Number: 6156902
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/31/2026
• 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