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

Catalog Number	100/136/075
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone, (b)(6).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
It was reported that post-procedure, the balloon was deflated for removal but it remained inflated.Photos are enclosed.There was patient involvement.
Additional Manufacturer Narrative
No product sample was received; therefore, functional testing could not be performed.One photo of the affected device was received, and confirmed the reported deflation of the device.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Without a sample for testing, the investigation could not identify a root cause.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• 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: 22568173
• Report Number: 3012307300-2025-08772
• Device Sequence Number: 9237497
• Product Code: BTR
• UDI-Device Identifier: 15019315021329
• UDI-Public: (01)15019315021329(17)290501(10)6001230
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K931735
• 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): 07/30/2025

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: Lay User/Patient
• Device Catalogue Number: 100/136/075
• Device Lot Number: 6001230
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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