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

Model Number	198-35L---802
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Month and year have been provided, day in 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 during the pre-use check, the customer noticed air was unable to be put in the blue cuff.No patient injury reported.No additional information is available for this complaint.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Two (2) photos were provided and reviewed as part of the device analysis.Photo one showed an endobronchial tube next to its original packaging, the whole device was visible; no damage or dysfunctional conditions was observed.Photo two showed a close-up of the union between the bronchial inflation line and endobronchial tube where itwas observed to be occluded.One product was returned and visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The join between the bronchial inflation line and endobronchial tube was observed to be occluded.No other damage or other dysfunctional conditions that could cause the reported failure were observed.The product was tested for cuff functionality by connecting the bronchial inflation pilot balloon to air and the cuff was attempted to be inflated.The bronchial inflation pilot balloon inflated as intended, but the cuff did not inflate fully confirming the complaint.A root cause was occlusion due to excessive solvent caused by failure to properly follow manufacturing procedure.A device history record (dhr) review showed no discrepancies or nonconformance's during the manufacturing of the reported lot number.Awareness notification was made to production personnel to explain the importance of adhering to, and following, procedure.

• Brand Name: PORTEX ENDOBRONCHIAL TUBE
• Common Device Name: TTUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATIO
• 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: 16695325
• Report Number: 3012307300-2023-03722
• Device Sequence Number: 12180040
• Product Code: CBI
• UDI-Device Identifier: 15019315058615
• UDI-Public: 15019315058615
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/31/2023

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: 06/17/2025
• Device Model Number: 198-35L---802
• Device Catalogue Number: 198-35L
• Device Lot Number: 4287228
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/22/2023
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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