MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES POLAR; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/136/085
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the customer noticed the cuff was unable to be inflated and leakage of air was observed.No patient injury.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.Pictures and a sample was received for evaluation.During inspection of the returned photos, a top view of a tracheal product is observed in one of the pictures, two are focused over the cuff where damage can be seen on the cuff surface.The returned sample was visually inspected under normal conditions of illumination according to procedure.The damage was observed on pictures and was found on the sample received; thus the failure mode is confirmed.The occurrence of this failure condition could be caused by not following the method during manufacture.No action taken.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12270457
• Report Number: 3012307300-2021-08013
• Device Sequence Number: 11854763
• Product Code: BTR
• UDI-Device Identifier: 15019315021527
• UDI-Public: 15019315021527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 01/21/2024
• Device Model Number: 100/136/085
• Device Catalogue Number: 100/136/085
• Device Lot Number: 3757832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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