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

Catalog Number	100/166/075
Medical Device Problem Codes	Decrease in Pressure (1490); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
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 the cuff pressure decreased, the cuff was leaking at the pilot balloon while operation was in process.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One photo and one video were included for evaluation.Visual and functional testing could not be performed.According to the photo and video received, a leak was observed in the pilot balloon confirming the customer's reported problem.The potential root cause of leakage at inflation line could be enough solvent at joint valve-pilot balloon.A quality alert was generated as a preventive action for leaks at joint valve-pilot balloon.The device history review of the reported lot number found no non-conformities during the manufacturing process.
Additional Manufacturer Narrative
D9: date returned to mfg.: 11/26/2024.H3 and h6.Codes: updated.Device evaluation update: received five (5) new unused tracheal tubes from the reported lot number.As received, there was no damage or anomalies observed.Each of the five (5) cuffs were inflated fully with 20 ml of air as per the instructions for use (ifu) with an icu medical provided syringe.No leaks were observed.The complaint of pilot balloon leakage can be confirmed but not replicated due to the original sample not being returned for a full comprehensive evaluation.

• Brand Name: PORTEX SILICONIZED NASAL 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: 20293197
• Report Number: 9617604-2024-00752
• Device Sequence Number: 15485512
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: (01)15019315054099(17)280213(10)4370560
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 100/166/075
• Device Lot Number: 4370560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 03/14/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/13/2024; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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 Sex: Unknown