MAUDE Adverse Event Report: ICU Medical Czech Republic a. s. Portex Blue Line Ultra SuctionAid Cuffed Tracheostomy Tube & Inner Cannula; Tube, tracheostomy (w/wo connector)

Catalog Number	100/870/080CZ
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: Portex Blue Line Ultra SuctionAid Cuffed Tracheostomy Tube & Inner Cannula
• Common Device Name: Tube, tracheostomy (w/wo connector)
• Manufacturer (Section D): ICU Medical Czech Republic a. s.; olomoucká 306; hranice NA 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50876427
• Report Number: 3011237704-2026-00012
• Device Sequence Number: 16138152
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: (01)15019315104862
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• PMA/510(K) Number: K030570
• 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
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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