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

Model Number	100/179/055
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, leakage of air from the cuff was detected.No patient injury or adverse affects.No additional information is available for this complaint.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Photos received: six photos were included in agile attachments for evaluation; photos showed a damage on tip of the tube.Samples received: two samples were received in used conditions without original package.Visual inspection results: no defects were found.Leak testing: the returned samples were connected to a machine to identify any leak.Results: gas leakage was detected, the complaint was confirmed.Customer complaint notification was performed on 25-jul-2022 to personnel to make them aware of the reported failure mode.The cause of the reported problem was traced to the manufacturing process.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.

• Brand Name: PORTEX ENDOTRACHEAL TUBE WITH HOLDER AND CONNECTOR
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15077506
• Report Number: 3012307300-2022-13895
• Device Sequence Number: 14780944
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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): 11/04/2022

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: 08/01/2026
• Device Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• Device Lot Number: 4169638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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