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

Catalog Number	100/899/070CZ
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used device was returned for investigation.The devices were visually inspected, the clamping mechanism was observed to be in an open state, not fully closed nor clamped tightly.During functional testing, the locking lever was disassembled and reassembled correctly.After reassembly, the locking lever was confirmed to operate correctly.The complaint of a loose component cannot be confirmed nor replicated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Event or Problem Description
It was reported that the patient had issues with tracheostomy tube where clip doesn¿t hold and tube migrates.To resolve the issue a new tracheostomy tube was inserted.There was patient involvement but no patient harm.

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no.4; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24078862
• Report Number: 3012307300-2026-00357
• Device Sequence Number: 5828043
• Product Code: BTO
• UDI-Device Identifier: 15019315060465
• UDI-Public: (01)15019315060465(17)300106(10)6078092
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: Other
• Device Catalogue Number: 100/899/070CZ
• Device Lot Number: 6078092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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 Age: 62 YR
• Patient Sex: Female