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

Model Number	100/199/085
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.Six photos and one sample device were received for investigation.The reported issue was confirmed in both the photos and sample device, which demonstrated that the device was printed with a size 8.0, but the labeling was printed with 8.5.The investigation attributed this condition to an error during the manufacturing process.A review of manufacturing device history found no discrepancies or anomalies.A notification of this complaint's details was made to manufacturing personnel and complaint information will continue to be monitored.
Event or Problem Description
It was reported that before opening the package, the customer noticed the product label on the package read 100/199/085, but the internal diameter of the actual product in the package was 8.0 mm.No adverse patient effects were reported by the customer.It was reported that no further information is available.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• 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: 17204064
• Report Number: 3012307300-2023-06662
• Device Sequence Number: 5540420
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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
• 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: 09/28/2024
• Device Model Number: 100/199/085
• Device Catalogue Number: 100/199/085
• Device Lot Number: 3866336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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