MAUDE Adverse Event Report: ICU MEDICAL, INC. PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/070
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).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 locking mechanism on the tracheostomy tube did not hold the tube securely in place.On several occasions, the tube slipped outward, requiring readjustment and repositioning.This tracheostomy tube was inserted on (b)(6) 2026.On (b)(6) 2026, it was noted that the tracheostomy tube had slipped out and that a greater portion of the tube was visible outside the wing.An ent physician repositioned the tube by advancing it 2¿3 cm.It was observed that the tube was not fully secured but appeared to be held more firmly when the blue locking mechanism was pressed completely to the bottom rather than only to the same level as the white plastic component.On (b)(6) 2026, it was again observed that the tube had migrated relative to the wing.The tube was repositioned downward.On (b)(6) 2026, the tube had once again moved upward relative to the wing by approximately 2¿3 cm, and it became evident that the locking mechanism was not functioning properly.The device was replaced with a new portex uniperc tracheostomy tube from a different lot number.There was patient involvement but no injury.However, several distressing episodes occurred during which breathing function was compromised.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25703610
• Report Number: 3012307300-2026-06868
• Device Sequence Number: 15815813
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: (01)15019315060434(17)280807(10)4418874
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2026

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: 100/897/070
• Device Lot Number: 4418874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COUGH-ASSIST MACHINE, UNK MFR; VENTILATOR, UNK MFR
• Patient Sex: Unknown