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

Model Number	100/111/020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Hydrocephalus (3272)
Date of Event	03/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3, h6: no product or pictures were returned.The reported complaint could not be confirmed, and a probable cause could not be determined.If the product is returned this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that an preterm infant required intubation for ongoing respiratory management.During a planned upsizing of the endotracheal (et) tube, the infant had a 3rd episode of a typical intubation finding and required use of a recalled size 2.0 et tube.The tube was used in the knowledge that it had been recalled but was used as a lifesaving intervention.The infant was subsequently transferred to another neonatal unit for ear, nose, and throat (ent) review, and the et tube was straightforward, and a suction catheter could be passed through the et tube to provide et suction.The infant had a size 2.0 ent tube inserted in the early hours on (b)(6) 2025, (b)(6) 2025 as an emergency procedure prior to the above intubation.It was reported to be unknown what brand of ent tube that was, and it was not possible to a suction catheter via that et tube.The infant had bilateral grade 4 intraventricular hemorrhages (ivhs) with early hydrocephalus evident on scan.Care was re-oriented on (b)(6) 2025, and the infant died.

• Brand Name: PORTEX ENDOTRACHEAL TUBE, SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; industrial internacional; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22035626
• Report Number: 3012307300-2025-05793
• Device Sequence Number: 15650502
• Product Code: BTR
• UDI-Device Identifier: 15019315018831
• UDI-Public: (01)15019315018831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100/111/020
• Device Catalogue Number: 100/111/020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown