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

Model Number	198-37L
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.Visual and functional tests were performed.One (1) sample was returned for evaluation, the sample was received in unused conditions within the original package.The returned sample was visually inspected at 12? to 16? under normal conditions of illumination.All results were found to be within drawing specification.Black small stain was detected on tube; the complaint was confirmed.Based on the analysis conducted in the sample provided, the black stain on the tube is within specification.The root cause of the reported issue was not determined.
Event or Problem Description
It was reported that during a pre-use check, the customer noticed a black foreign substance was adhered to the product.No patient injury.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16860619
• Report Number: 3012307300-2023-04962
• Device Sequence Number: 5460368
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 06/04/2023
• Device Model Number: 198-37L
• Device Catalogue Number: 198-37L
• Device Lot Number: 3986465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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