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	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Pictures and a sample were received for evaluation.Visual and functional testing were performed.In the pictures it was observed that a unit from a part number was label incorrectly.Visual inspection of the returned sample observed the incorrect size of the product inside the packaging.A audit of the production floor was conducted by the quality engineer.Line clearance records were reviewed; no discrepancies were found.Packaging unit carton without divider operation was reviewed; production personnel are following the procedure, no discrepancies were found.Packaging unit carton without divider operation was audited during thirty two (32) units; no discrepancies or mixed materials were detected during the thirty two (32) units.Production personnel perform a 100% visual inspection in order to verify that the printed tube size and hand matches with the corresponding product label.The most probable root causes is the line clearance procedure was not properly followed.Several actions were put in place to reinforce the packaging inspection.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that immediately after opening the package of a product the incorrect size of the product was in the package.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; 2-jo kudaru, kawaharamachidori; minneapolis, MN 55442
• MDR Report Key: 15353889
• Report Number: 3012307300-2022-17699
• Device Sequence Number: 5863847
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2022

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 Expiration Date: 08/06/2022
• Device Model Number: 198-37L
• Device Catalogue Number: 198-37L
• Device Lot Number: 3846367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 09/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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