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

Model Number	100/134/060
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that portex endotracheal tubes did not have markings on the vocal cords with sizes 5, 5.5, and 5.6.The product problem was observed upon opening of the package.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Four pictures of a portex endotracheal intubation tube polar were received according to the drawing specification t02299 issue 6, therefore the complaint was not confirmed.Ten samples of a portex endotracheal intubation tube polar from part number 100/134/060 were received in unused conditions inside their original package.The returned samples were visually inspected at 12" to 16" and normal conditions of illumination.No missing marks were found, the samples met with drawing specification t02299 issue 6; the complaint was not confirmed.The was no fault found with the returned samples.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11308995
• Report Number: 3012307300-2021-01124
• Device Sequence Number: 793108
• Product Code: BTR
• UDI-Device Identifier: 15019315021015
• UDI-Public: 15019315021015
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: No Information
• Device Expiration Date: 03/13/2025
• Device Model Number: 100/134/060
• Device Catalogue Number: 100/134/060
• Device Lot Number: 3946329
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1