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

Model Number	100/134/050
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
Other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX
• 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: 11308342
• Report Number: 3012307300-2021-01114
• Device Sequence Number: 793102
• Product Code: BTR
• UDI-Device Identifier: 15019315020872
• UDI-Public: 15019315020872
• 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: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Model Number: 100/134/050
• Device Catalogue Number: 100/134/050
• Device Lot Number: 3901335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1