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

Catalog Number	100/166/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00144-00.The date of that submission was 20-feb-2025.
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.Investigation summary: one (1) used.List #100/166/075, tracheal tube siliconised pvc soft-seal cuff oral/nasal7.5mm 10/bx; lot #unknown was returned for evaluation.Testing and inspected, cannot replicate failure ¿a0125 - cuff deflation / leakage¿.Video of testing attached.A device history record could not be completed as no lot number was received.
Event or Problem Description
It was reported that there was an air leak from the cuff.There was no disinfection or sterilization, and no infectious disease occurred.There was no patient harm or adverse events reported as a result of the event.

• 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; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21858619
• Report Number: 3012307300-2025-04483
• Device Sequence Number: 7888372
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: (01)15019315054099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 100/166/075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: 03/22/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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