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

Catalog Number	100/189/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 43-year-old-female patient was admitted to the operating room.The electrocardiogram (ecg) monitoring showed that the suction endotracheal tube was normal at 7.0.After the induction intubation, the patient held their breath immediately after the balloon was inflated.The patient also held their breath after multiple inflations.They then had to replace the new suction endotracheal tube and intubate again.The damaged endotracheal tube was removed and immersed in water before inflating.It was found that there was a leak at the junction of the balloon extension tube and the endotracheal arm.No substantial harm was caused to the patient.
Additional Manufacturer Narrative
H3: neither samples nor pictures were received for analysis.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF 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: 21942687
• Report Number: 3012307300-2025-05111
• Device Sequence Number: 8691551
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: (01)15019315059520(17)270707(10)4292824
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 100/189/070
• Device Lot Number: 4292824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2022
• 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 Sex: Unknown