MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. TPORTEX EYE SOFT-SEAL TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/179/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name unknown.No device or device photo was returned for investigation.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.
Event or Problem Description
It was reported that during use the balloon was inflated after the catheterization, and the balloon was found to be leaking, so it was removed.The second endotracheal tube that passed the air leak test was replaced, and the air still leaked after the catheter was inserted, so it was removed.The third endotracheal tube that passed the air leak test was replaced, and the air still leaked after the catheter was inserted, so it was removed.There was patient involvement, and no patient harm reported.

• Brand Name: TPORTEX EYE SOFT-SEAL TRACHEAL TUBE
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19967496
• Report Number: 9617604-2024-00641
• Device Sequence Number: 8784721
• Product Code: BTR
• UDI-Device Identifier: 15019315022135
• UDI-Public: (01)15019315022135(17)280701(10)4403645
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 100/179/075
• Device Lot Number: 4403645
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Male