MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/179/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Encephalopathy (1833); Cardiogenic Shock (2262)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no samples were received for analysis of this complaint.The device history record was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Complaint for the failure mode "a0282 - leaking." could not be confirmed by investigation as no samples nor pictures was provided by the customer.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, this complaint will be reopened for further investigation.
Event or Problem Description
It was reported that the patient was admitted to the hospital with ""chest tightness and pain, shortness of breath for half a month, and aggravated for one day"".Due to the patient's cardiogenic shock, hypoxic-ischemic encephalopathy, and poor ability to cough and produce sputum spontaneously, coronary angiography was planned to be performed urgently, and in order to clear the airway, ensure oxygen supply, and clear airway secretions, the patient was given bedside fibrobronchoscopic nasotracheal intubation and alveolar lavage.Before catheterization, the first endotracheal intubation was tested, and passed, and the balloon was inflated after the catheterization, and the airbag was found to be leaking, and the leaky tracheal intubation was removed, and the endotracheal intubation with good quality was replaced for catheterization.There was patient involvement and no patient harm/adverse event reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20799534
• Report Number: 9617604-2024-00899
• Device Sequence Number: 12495885
• Product Code: BTR
• UDI-Device Identifier: 15019315022128
• UDI-Public: (01)15019315022128(17)280906(10)4425931
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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 Catalogue Number: 100/179/070
• Device Lot Number: 4425931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female