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

Model Number	100/189/070
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the endotracheal tube has some external material sticking to the tube.It was observed, at the time of insertion.There has been no report of patient involvement, or no observable clinical symptoms, or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed, during visual inspection when the device was observed, to have a foreign material present on it.On further analysis, the foreign material was determined, to be similar to lidocaine anesthetic.The investigation attributed the observed material to user interface, as the contamination likely occurred during use.A review of manufacturing device history records for the reported lot found no discrepancies or anomalies.No actions have been taken at this time.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL 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: jim vegel
• MDR Report Key: 17199115
• Report Number: 3012307300-2023-06618
• Device Sequence Number: 20229103
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: 15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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 Expiration Date: 08/01/2026
• Device Model Number: 100/189/070
• Device Catalogue Number: 100/189/070
• Device Lot Number: 4175611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown