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

Model Number	100/199/085
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the customer inserted the product into the patient, leakage of air from the cuff was observed.No patient injury was reported.No additional information is available for this complaint.
Additional Manufacturer Narrative
Date of event: month and year of event have been provided, day is unknown.Expiration date and manufacture date are unknown, lot number provided cannot be verified.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.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Three (3) photos and one (1) device received in used condition with the original packaging opened.The returned sample was visually inspected and no defects were found.A leak test was performed in which the cuff failed to remain inflated confirming the customer complaint.A root cause could not be determined however as no leaks were reported during the pre-use check it is most probable that the leak was due to improper use of the product.A device history record (dhr) review could not be performed as the lot number provided cannot be verified.No corrective actions were taken as the main cause of the leakage problem was improper use of the product.

• 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: 16678257
• Report Number: 3012307300-2023-03523
• Device Sequence Number: 20467956
• Product Code: BTR
• UDI-Device Identifier: 15019315022357
• UDI-Public: 15019315022357
• 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): 05/03/2023

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: 100/199/085
• Device Catalogue Number: 100/199/085
• Device Lot Number: 3390337
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2023
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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