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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "before intubation, put air in the cuff and check that it swells.After intubation, even if the operator put air in the cuff, it did not go in." there were no patient harm/adverse event reported.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00171-00.The date of that submission was 04-mar-2025.B3: day of event is unknown.H3: one device was received.Device was visually and functionally tested and the customer reported complaint was able to be confirmed.Maintenance for cuff rollers was made to prevent future damage to cuff on mar/28/2025.Upon reviewing the cuff rollers, it has been observed that wear on the tooling presents a potential risk of damage to the cuff.Maintenance is required, specifically polishing, to prevent irregularities on the surface of the rollers.A dhr review was unable to be completed as no lot number was provided.

• 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: 22020541
• Report Number: 3012307300-2025-05569
• Device Sequence Number: 12945066
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: (01)15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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