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

Model Number	100/199/065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	10/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned and are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review showed there were no discrepancies reported during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that a patient had multiple injuries which included a pelvic fracture (west), hemorrhagic shock, traumatic splenic rupture, rib fracture (western) emergency department for total splenectomy and arterial embolization.An endotracheal intubation was performed october 30th, with ventilator assisted breathing, and a postoperative transfer to the icu.Endotracheal tube fixed and managed smoothly, air bag pressure was normal, the patient was occasionally agitated, and sedatives continued to be used.When the patient's balloon pressure was measured the afternoon of november 2nd, the airbag pressure of the patient was measured, and abnormalities were found, and the ventilator alarmed abnormally.The patient coughed violently, and the voice in the throat was abnormal.Immediately checked the performance of the endotracheal tube and endotracheal re-intubation was performed.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; xiaoshan district; minneapolis, MN 55442
• MDR Report Key: 16533206
• Report Number: 3012307300-2023-02330
• Device Sequence Number: 17671537
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: 15019315022319
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2025
• Device Model Number: 100/199/065
• Device Catalogue Number: 100/199/065
• Device Lot Number: 3927052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male