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

Model Number	100/179/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a pre-use check, the cuff would not inflate.No patient injury was reported.
Additional Manufacturer Narrative
Four (4) photos and one device received in use condition with the original packaging opened.The device was visually inspected at a distance of 12 to 16 inches and normal conditions of illumination; no visual defects were detected in the device.A leak test was performed, and the cuff failed to inflate, the air remained in the pilot balloon confirming the complaint.A root cause was attributed to production personnel did not remove the hf" excess from the inflation line during manufacturing.A device history record (dhr) review showed no issues, nonconformance's reported during the manufacture of the reported lot number.Notification was made to all operations personnel as awareness to follow procedures.This issue will continue to be monitored and further actions taken accordingly.

• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima; minneapolis, MN 55442
• MDR Report Key: 16403969
• Report Number: 3012307300-2023-01444
• Device Sequence Number: 11594929
• Product Code: BTR
• UDI-Device Identifier: 15019315022081
• UDI-Public: 15019315022081
• 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): 06/20/2023

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: 100/179/050
• Device Catalogue Number: 100/179/050
• Device Lot Number: 4241736
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/01/2023
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2022
• 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