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

Catalog Number	100/127/025
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Decreased Respiratory Rate (2485)
Date of Event	06/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during patient use, the tracheal tube was correctly placed but ventilation was not possible, resulting in unstable vital signs.Comparing the tracheal tube with another tube showed that the latter was more rigid and did not kink easily.The patient required eight intubations, high fio2(fraction of inspired oxygen), a bronchoscopy.There was patient involvement and harm.
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
The following incident details are based on information received from the distributor through their direct contact with the facility customer: additional information from the distributor was received on (b)(6) 2026 stating that the patient expired.The distributer stated that after the patient was transferred to montreal children¿s hospital, the patient remained ¿critically ill and unstable¿ throughout the hospitalization.The distributor also indicated the clinical course was complicated by an intraventricular hemorrhage.The patient expired on (b)(6) 2026.According to the distributor, 8 devices were used to intubate the patient, and 7 are alleged to be portex endotracheal tubes.Of those 7, one lot number is known and the others are unknown.At this time, it is not known if all 7 devices were icu medical devices.This is report 1 of 2 referencing the same patient due to the item and lot numbers that were used during the event not being able to be verified at this time.The distributor stated that due to multiple risks inherent to extreme prematurity and complex postnatal clinical care, a definitive causal relationship between the reported events and the fatal outcome cannot be established at this time.Reporter file no.(b)(4) is specific to the portex endotracheal tube returned to icu that was allegedly 1 of the 7 utilized in treating the patient.The remaining 6 devices that allegedly failed with the patient were not returned for inspection.Reporter file (b)(4) is specific to the unknown devices.If further information about the devices and their item/lot numbers becomes available, it will be updated in following reports.
Additional Manufacturer Narrative
B2 - outcomes attributed to ae: updated, b2 - date of death: updated, b5 - describe event or problem: updated, d4 - expiration date: corrected, d4 - primary udi number: corrected, d9 - date returned to mfr: 07-jul-2026, h1 - type of reportable event: updated, h6 codes: updated.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.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 25669284
• Report Number: 3012307300-2026-06709
• Device Sequence Number: 16064153
• Product Code: BTR
• UDI-Device Identifier: 15019315019807
• UDI-Public: (01)15019315019807(17)301126(10)6127940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K790312
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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: Health Professional
• Device Catalogue Number: 100/127/025
• Device Lot Number: 6127940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2025
• 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: Death; Required Intervention; Hospitalization
• Patient Age: 5 MO
• Patient Sex: Unknown