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

Model Number	100/136/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the cuff was unable to be inflated.No patient injury reported.No additional information is available for this complaint.
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 required.
Additional Manufacturer Narrative
Other, other text: h6 conclusion codes: updated h10 device evaluation: four photos and one device were returned for investigation.The photographs showed the complaint sample.Visual inspection showed the device in used condition with its original packaging opened.No visual defects were detected in the sample.Functional testing confirmed that the obstruction was present at the bond of the inflation line and tube, the air flow was blocked and prevented the correct inflation of the balloon; confirming the customer complaint.A review of the device history record (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Based on the analysis conducted in the sample provided, the failure mode of inflation line occluded, was confirmed.It was determined that the occurrence of this failure condition could be due to the operator not removing the excess solvent from the inflation line during the manufacturing process.All mitigations in place were verified and it was confirmed they have been executed accordingly.Complaint monitoring will continue.

• 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: 16644460
• Report Number: 3012307300-2023-03273
• Device Sequence Number: 14825521
• 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): 04/20/2023

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 Model Number: 100/136/050
• Device Catalogue Number: 100/136/050
• Device Lot Number: 4204362
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/17/2023
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/20/2023
• 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