MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/815/080
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).H3: the device was received for evaluation.The lot history was reviewed; no relevant nonconformities were identified that may have contributed to the reported complaint.Visual and functional tests were performed, which confirmed the complaint of the disconnected pilot balloon.The probable cause was due to an incomplete solvent coverage application during assembly in tijuana.There was no further action taken.
Event or Problem Description
It was reported that the patient's tracheostomy tube pilot line was found to be disconnected from pilot balloon.When reinserted into balloon, was noted to still hold pressure but decision made to change trach tube for safety purposes.The trach tube was defective.Pilot line should not disconnect from balloon; appears it was not glued properly by manufacturer.There was patient involvement and no patient harm/adverse event.

• Brand Name: BLUSELECT 8.0, CUFFED, NON-FEN, W/WEDGE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23839419
• Report Number: 3012307300-2025-13609
• Device Sequence Number: 13251479
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: (01)15019517077360(17)280724(10)4413964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 101/815/080
• Device Lot Number: 4413964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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