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

Model Number	100/136/075
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Month and year of event have been provided, day is unknown.A product sample was received and is awaiting evaluation, investigation 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 found difficulty inflating and deflating the cuff.No report of patient injury.
Additional Manufacturer Narrative
Three photos and one sample device were received.Each photo depicted the complaint sample.The reported issue was confirmed during functional testing, when the sample device cuff failed to inflate.The issue was traced to the junction of the inflation channel being partially occluded.The root cause was determined to be failure to follow method during manufacture.A review of manufacturing device history records found no related nonconformance, however the investigation attributed the issue to a manufacturing error.Production personnel were notified of the complaint details, and trends will continue to be monitored, with actions taken as needed.

• Brand Name: PORTEX ENDOTRACHEAL TUBES
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16693172
• Report Number: 3012307300-2023-03681
• Device Sequence Number: 18005877
• Product Code: BTR
• UDI-Device Identifier: 15019315021329
• UDI-Public: 15019315021329
• 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): 05/31/2023

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: 100/136/075
• Device Catalogue Number: 100/136/075
• Device Lot Number: 4255366
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/22/2023
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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