MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX POLAR CLEAR ORAL SOFT SEAL TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/136/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was checked for leaks during pre-use checks.A cuff leak was detected.No adverse effects reported.
Additional Manufacturer Narrative
Other text: d3, g1, and g2 email is: (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 reportable information becomes available.
Additional Manufacturer Narrative
Other text: g1, h3, h6: updated one sample was returned in used condition, five photos were included for evaluation, the visual inspection was not able to detect any condition on the surface of the cuff or in the inflation system.The sample was inflated and submerged under water, the leak was identified in the joint of the valve and the pilot balloon.The complaint was confirmed.Based on the analysis conducted in the sample provided, the returned sample has a hole in the pilot balloon.This type of hole can be caused when the product is in contact with some sharp edge, the unit is observed used.However, 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 (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
D4: udi updated **udi related data quality updates only**.

• Brand Name: PORTEX POLAR CLEAR ORAL SOFT SEAL TRACHEAL TUBE
• 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: 18283989
• Report Number: 3012307300-2023-10949
• Device Sequence Number: 6043744
• Product Code: BTR
• UDI-Device Identifier: 15019315021305
• UDI-Public: (01)15019315021305(11)190104(17)231208(10)3735366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2024

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: 12/08/2023
• Device Catalogue Number: 100/136/065
• Device Lot Number: 3735366
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/15/2023
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/21/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• 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