MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBE, SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/090
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: d4: udi section is unknown.G5: 510k is blank, this catalog number is not sold in the united states.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 during pre-use testing, air comes out.Air cannot be injected during preliminary inspection before intubation.No harm, injury or adverse effects have been reported.
Additional Manufacturer Narrative
G1,2 email is: regulatory.Responses@icumed.Com.One device was received in used condition; two photos were also included.During the initial visual inspection, it was not possible to detect any condition on the surface of the cuff or in the inflation system.Per functional leak test, the sample did not pass the test.To identify the leak, the sample was inflated with the use of a syringe, then submerged under water, the leak was identified in the valve of the pilot balloon.The complaint was confirmed.Other analysis, notes included in the instructions for use (ifu), are to review the integrity of the inflation system.Based on the analysis conducted in the sample provided, the returned sample had a leak in the valve of the pilot balloon, this leak can occur during connection of the air supply to the valve due to excessive pressure being applied to the connection causing damage to the valve, root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX ENDOTRACHEAL TUBE, SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17856460
• Report Number: 3012307300-2023-09488
• Device Sequence Number: 3278501
• Product Code: BTR
• UDI-Device Identifier: 15019315054129
• UDI-Public: (01)15019315054129(11)200613(17)250628(10)3990332
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2024

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 Expiration Date: 06/28/2025
• Device Model Number: 100/166/090
• Device Catalogue Number: 100/166/090J
• Device Lot Number: 3990332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/27/2023; Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/22/2023; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown