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

Model Number	100/136/050
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that during the pre-use check, the customer noticed the cuff was unable to be deflated.No patient injury was reported.
Additional Manufacturer Narrative
One device and three photographs were returned for investigation.The sample was in used condition without its original packaging.Visual inspection showed the inflation line was occluded.Functional testing was performed, inflating the cuff with a syringe; the cuff would not inflate ,confirming the customer's complaint.A device history report (dhr) review was conducted and there were no issues or nonconformances reported during the manufacture of this lot.The leak was detected using the leak tester machine.Based on the analysis conducted in the sample provided, cuff inflation/deflation failure mode was confirmed.Therefore, according to the occurrence of this failure the condition could be caused by failure to properly follow the manufacturing method procedures leak testing.Customer complaint notification was made to production personnel to explain the importance to adherence or following in the procedure.

• 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: 16113116
• Report Number: 3012307300-2023-00179
• Device Sequence Number: 17581043
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: 15019315021053
• 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
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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 Model Number: 100/136/050
• Device Catalogue Number: 100/136/050
• Device Lot Number: 4204362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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