MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOBRONCHIAL DOUBLE LUMEN; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-35L
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event problem and evaluation codes: updated.Device evaluation: the device was returned for investigation.A visual inspection was performed.Visual inspection results: the tip of the tube is bent, thus the failure mode reported is confirmed.The customer stated problem was duplicated.A non conformance report was created in order to perform a complete cause analysis for the failure mode reported, which identified two causal factors as main contributors that cause an impact on the curvature of the tube tip: 1-method: bending tube tip method not clear.2-measurement: manufacturing procedure is not clear in which cavity from the gauge use to confirm the tube tip by the production operator according to the part number (one gauge for all tube sizes).The cause of the reported problem was traced to the manufacturing process.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that the curvature of 35 fr left dlt not conforming to standard.In final position of dlt bronchial current pointing downward instead of to the left.

• Brand Name: PORTEX ENDOBRONCHIAL DOUBLE LUMEN
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; teletech park 01-23/25; minneapolis, MN 55442
• MDR Report Key: 15778539
• Report Number: 3012307300-2022-27050
• Device Sequence Number: 5096729
• Product Code: CBI
• UDI-Device Identifier: 15019315058615
• UDI-Public: 15019315058615
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K953483
• 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): 11/11/2022

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: 05/22/2023
• Device Model Number: 198-35L
• Device Catalogue Number: 198-35L
• Device Lot Number: 3977828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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