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	100/189/080
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Event or Problem Description
It was reported that an intubated patient was treated with a ventilator, when an endotracheal tube with subglottic channel no.8.0 was inserted.The ventilator had a slight difference between inspiratory and expiratory tidal volume, but no difficulty in ventilating the patient.In connection with transferring the patient to a different hospital, a small wheezing sound is heard, and a decision is made to change the tube.Upon inspection, it turns out that there is a hole in the tracheal tube around the welding.The tracheal tube is saved.There was patient involvement.
Additional Manufacturer Narrative
D9: 18-aug-2025.H3: one used product was received from the customer for evaluation.As received, there were no damages or anomalies observed.Functional testing was performed, and the trach cuff and pilot balloon inflated successfully.No leaks were observed from the inflation line, pilot balloon, nor trach cuff.The reported issue was not confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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 n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22566845
• Report Number: 3012307300-2025-08764
• Device Sequence Number: 9348149
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: (01)15019315059544(11)291101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 100/189/080
• Device Lot Number: 6066712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown