MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/870/090
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
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 information becomes available.
Event or Problem Description
It was reported that the bluselect suction aid tracheostomy tube exhibited a defect near the flange (neck plate) attachment point, resulting in the tube becoming nearly detached.A replacement tube was provided after the issue was identified.According to the patient's assistants, the issue was not attributed to handling error.There was patient involvement; however, no injury was reported.This report captures the two of two occurrences.
Additional Manufacturer Narrative
D3 - postal code, h3, h6: updated.D3 - zip code: must be blank.The suspect product was not returned for evaluation as it was discarded.However, a photo of the sample was provided.The device history record was reviewed and was confirmed that there were no anomalies noted.The lot history review was performed, and it was confirmed that there were no previous conformities noted.Observation of the photo confirmed that there was a defect near the attachment point at the flange or neck plate and a crack was observed on the port.The allegation made by the complainant was confirmed.However, the probable root cause of the event was unable to be determined.
Additional Manufacturer Narrative
D3 - postal code, h6: updated.D3 - zip code: must be blank.The supplemental record was created to correct the following field: 'h3 - device evaluation by manufacturer' and is changed from 'yes' to 'no'.

• Brand Name: BLUSELECT 9.0, SUCTIONAID, CUFFED, NON-FEN, 1/EA
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25482048
• Report Number: 3012307300-2026-06002
• Device Sequence Number: 13392200
• Product Code: BTO
• UDI-Device Identifier: 15019517078022
• UDI-Public: (01)15019517078022(17)300820(10)6131496
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 101/870/090
• Device Lot Number: 6131496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 06/23/2026; 06/23/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/08/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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