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

Catalog Number	101/810/090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plastic that holds patient's "neck tie" in place had snapped causing the tracheostomy to come loose.The tracheostomy broke at the site where the fabric neck tie wraps around the soft plastic of the base plate of the flange.The broken tracheostomy was removed and replaced with a new one.
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.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 reportable information becomes available.
Additional Manufacturer Narrative
D3: updated.H3 and h6 codes: updated.No physical product sample was returned for evaluation; however, four (4) images were provided.Review of the images showed that the flanges of the tracheostomy tube were damaged, with slit-like defects visible on both ends.The reported complaint of damage/breakage is confirmed based on the returned images.A review of the lot history identified no nonconformities that could have contributed to the complaint.The probable cause appears to be associated with the use of the velcro strap during intubation, which may have contributed to stress on the eyelet and subsequent damage.

• Brand Name: PORTEX BLUSELECT CUFFED TRACHEOSTOMY TUBE
• 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: 24502129
• Report Number: 3012307300-2026-01982
• Device Sequence Number: 9943240
• Product Code: BTO
• UDI-Device Identifier: 15019517077032
• UDI-Public: (01)15019517077032(17)291127(10)6058739
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: Lay User/Patient
• Device Catalogue Number: 101/810/090
• Device Lot Number: 6058739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• 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