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	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 upon insertion a leak was discovered.The leak was found at the top of the tracheostomy tube after removal.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
G4 - pma/510(k) #, h3, h6: updated.The suspect product was returned for evaluation.Visual inspection confirmed that there were no anomalies found.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.Functional test revealed that there was a leak observed at inflation line-trach body connection and a damage was present on the end of the inflation line bond.The allegation made by the complainant was confirmed.However, the probable root cause of the event was unable to be determined.

• 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: 24688632
• Report Number: 3012307300-2026-02894
• Device Sequence Number: 13272281
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: (01)15019315060434(17)290716(10)6031856
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 6031856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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