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

Model Number	198-37L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.A product sample and pictures were received for evaluation.No discrepancies were observed from pictures received.Visual and functional testing were performed.No discrepancies were observed.The sample was tested for occlusion by manually inflating with a syringe to the tracheal and bronchial cuff.There was not resistance to inflate and deflate the cuffs.The complaint was not confirmed.The root cause could not be established as no issue was found.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
Event or Problem Description
It was reported that during a pre-use check, the customer noticed something was wrong with the cuff.No other information was provided.No patient injury was reported.

• Brand Name: PORTEX ENDOBRONCHIAL DOUBLE LUMEN
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2jo kudaru, kawaharamachidori,; minneapolis, MN 55442
• MDR Report Key: 15369264
• Report Number: 3012307300-2022-18079
• Device Sequence Number: 1622924
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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 Model Number: 198-37L
• Device Catalogue Number: 198-37L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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