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

Catalog Number	100/133/
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
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 reportable information becomes available.
Event or Problem Description
It was reported that, on three instances, the balloon has deflated on its own.It was checked before use with no issues found.The patient was under anesthetic and had not been affected medically.The procedure was completed with a noted delay.A different product lot was used instead.There was patient involvement, but no injury.
Additional Manufacturer Narrative
Five new units were received for evaluation.All units were functionally tested, and no leaks that could indicate the reason for deflation were found on any of the five pieces tested.No deflation was observed during functional testing.The units tested normally at the time of evaluation.There were no relevant nonconformances found during a lot history review.
Additional Manufacturer Narrative
G3 - date received by mfg and reporting become aware date submitted on report ref # 3012307300-2025-12617-01 corrected.

• Brand Name: PORTEX TRACHEAL TUBE MAXILLO FACIAL
• 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: 23597418
• Report Number: 3012307300-2025-12617
• Device Sequence Number: 10314643
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: (01)15019315020346(17)300702(10)6121876
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2025

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: 100/133/
• Device Lot Number: 6121876
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025; 11/26/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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
• Patient Sex: Unknown