MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. SIMS BLUE LINE ENDOTRACHEAL; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-41L
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the device was not received in the intended cardboard box packaging.The endobronchial tube was received in a sealed pouch without the five accessories that are supposed to be included.No patient involvement.
Additional Manufacturer Narrative
Other text: h6.Evaluation codes: updated.Device evaluation: no product was returned.No photographic or diagnostic evidence was provided by the customer.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the device is later returned, the complaint will be reopened and an investigation will be completed.

• Brand Name: SIMS BLUE LINE ENDOTRACHEAL
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17226624
• Report Number: 3012307300-2023-06859
• Device Sequence Number: 6969725
• Product Code: CBI
• UDI-Device Identifier: 15019315058646
• UDI-Public: 15019315058646
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 05/04/2025
• Device Model Number: 198-41L
• Device Catalogue Number: 198-41L
• Device Lot Number: 4274681
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2022
• 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