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

Catalog Number	100/810/090
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
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.
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
H6.Codes: updated.Device evaluation: no product samples were received for investigation.Four (4) customer images were returned showing the condition of the device and a photo of the intubated patient setup.The flanges of the trach tube were observed to be damaged, with slit damage present on both flange ends.The complaint of damage/broken can be confirmed based on the returned images.The probable cause is due to the velcro strap used during intubation, which may have contributed to stress on the eyelet and subsequent damage.A device history record review could not be performed as the lot number was unknown.

• Brand Name: PORTEX BLUE LINE ULTRA 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: 24503018
• Report Number: 3012307300-2026-01984
• Device Sequence Number: 13251859
• Product Code: BTO
• UDI-Device Identifier: 15019517076325
• UDI-Public: (01)15019517076325
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 100/810/090
• 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: 05/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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