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

Model Number	198-35L
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, the blue cuff would not be inflated.No patient injury.
Additional Manufacturer Narrative
H6: health impact and evaluation codes: updated h10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and four photos were received for evaluation.Visual inspection found a hole in pilot balloon was detected, therefore leakage was detected, complaint was confirmed.The root cause of the reported issue was found to be manufacturing - damage during handling.Customer complaint notification was performed on (b)(6) 2022 to production personnel as awareness to failure mode reported.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATIO
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14787085
• Report Number: 3012307300-2022-12415
• Device Sequence Number: 5935594
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 10/18/2024
• Device Model Number: 198-35L
• Device Catalogue Number: 198-35L
• Device Lot Number: 4199885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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