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

Model Number	197EBT
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was deformation on inside packing with outer carton intact.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
Date of event is unknown, no information has been provided to date.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16097295
• Report Number: 3012307300-2023-00085
• Device Sequence Number: 6669231
• Product Code: CBI
• UDI-Device Identifier: 15019315058554
• UDI-Public: 15019315058554
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K953483
• 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,Followup
• Report Date (Section B): 02/15/2023

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: 08/01/2025
• Device Model Number: 197EBT
• Device Catalogue Number: 197-35R
• Device Lot Number: 4299362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown