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

Catalog Number	100/179/075
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: no product was received for analysis.Without the return of the product a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.The service history review had no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported in the report that the ventilator of a 76-year-old male patient repeatedly sounded the alarm that the minute ventilation volume was too low.The doctor found that the endotracheal tube balloon was leaking, and the endotracheal tube was urgently replaced under the guidance of a fiberoptic bronchoscope.After the tube was replaced, the alarm disappeared, and the ventilator ventilation returned to normal.There was patient involvement but no patient harm.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22496299
• Report Number: 3012307300-2025-08295
• Device Sequence Number: 6975341
• Product Code: BTR
• UDI-Device Identifier: 15019315022135
• UDI-Public: (01)15019315022135(17)280322(10)4385685
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/179/075
• Device Lot Number: 4385685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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 Age: 76 YR
• Patient Sex: Male