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

Catalog Number	198-37L
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.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 after inflating the cuff, the client attempted to deflate in order to extubate the patient before awakening from anesthesia.However, the air in the cuff did not escape.The customer suspected a blocked inflation line.Patient injury or adverse effects have not been reported.
Additional Manufacturer Narrative
One device was received in used condition without the original package.Per visual inspection, no visual defects were detected.Per functional testing the device inflated and deflated normally, and no leaks were detected in any cuff.The complaint was not confirmed.No other analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No root cause could be determined since the complaint was not confirmed.No corrective actions were taken.

• Brand Name: PORTEX ENDOBRONCHIAL TUBE
• Common Device Name: TUBE, TRACHEL/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: 17435217
• Report Number: 3012307300-2023-07662
• Device Sequence Number: 8942413
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: 15019315058622
• 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): 10/27/2023

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: 07/21/2025
• Device Catalogue Number: 198-37L
• Device Lot Number: 4292770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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