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

Catalog Number	100/897/080CZ
Medical Device Problem Codes	Leak/Splash (1354); Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D3, h1: corrected.B2, 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.Leak test was performed and it was found that there was no leakage detected.The allegation made by the complainant could not be confirmed and the probable root cause of the event could not be identified.
Event or Problem Description
It was reported that there were cuff leaks involving portex adjustable flange tracheostomy tubes, with one occurring within 24 hours of a tube exchange.On examination, there was no obvious air leak detected when the tube was fully submerged under water at a cuff pressure of 30 cmh2o.However, they did observe a drop in cuff pressure from 30 cmh2o to 28 cmh2o over a 30-minute period.Established artificial airway was being administered or performed.There was delay in therapy.It was not reported to regulatory authority.The event involved death or serious deterioration of a person.There was patient involvement and patient harm or adverse event reported.Patient desaturated prior to and during tracheostomy changeover.Patient recovered without morbidity or mortality.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• 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, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, MN 60045 ; 2247062300
• MDR Report Key: 24883416
• Report Number: 3012307300-2026-03727
• Device Sequence Number: 10494895
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: (01)15019315107207(17)300630(10)6098100
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 6098100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown