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

Model Number	198-32L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Five photos and one sample was returned for evaluation.The sample was received in used condition within its original package.Visual and functional testing were performed.Visual inspection determined that no defects were observed.Functional testing found that there was resistance inflating and deflating the cuff; occlusion failure mode was confirmed.The occurrence of this failure condition could be caused by method not followed (excess solvent thf at joint) at manufacture.Operator of device was unknown.No information has been received to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that when inflating and deflating the tracheal cuff at a pre-use check, the customer felt extreme resistance through it.No patient injury was reported.

• Brand Name: PORTEX BLUE LINE 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15467418
• Report Number: 3012307300-2022-20149
• Device Sequence Number: 20553352
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• 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): 09/22/2022

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: 03/18/2023
• Device Model Number: 198-32L
• Device Catalogue Number: 198-32L
• Device Lot Number: 3955980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• 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: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2020
• 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