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

Catalog Number	100/136/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the device had "weak cuff swelling".Even if air was put in with a cuff pressure gauge, the swelling of the cuff was not good.Patient involvement unknown.
Additional Manufacturer Narrative
B3: month and year of event have been provided.Day is unknown.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
Device evaluation: two devices in used conditions with the original packaging opened were received.Functional testing found in both samples that air was identified as being trapped in the pilot balloon.Also noted in both samples was an obstruction that can be seen at the junction.The complaint was confirmed.Root cause was attributed to an occlusion at the connection of the inflation line to the tracheal tube.This could be caused by the manufacturing method not being followed.The operator did not remove the "thf excess" from the inflation line.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.All mitigations in place were verified and it was confirmed the have been executed accordingly.This failure condition will continue to be monitored in this product for threshold or escalation.
Event or Problem Description
It was reported that during pre-testing, the device had "weak cuff swelling".Even if air was put in with a cuff pressure gauge, the swelling of the cuff was not good.No adverse effects reported.

• Brand Name: PORTEX TRACHAEL TUBE POLAR CLEAR
• 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: jim vegel
• MDR Report Key: 17430923
• Report Number: 3012307300-2023-07641
• Device Sequence Number: 6834996
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: 15019315021053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 100/136/050
• Device Lot Number: 4204362
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/12/2023
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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