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

Catalog Number	100/189/080
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Irritability (2421)
Date of Event	04/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ballon of the tracheal tube seemed to be leaking.This caused the patient to be continuously intubated, sedated and put on analgesic medications (remifentanil and ciprofol) and appeared to be intermittently irritable and could not communicate effectively.The care team eventually changed the endotracheal tube.
Additional Manufacturer Narrative
This file was originally incorrectly filed under registration number mrn 9617604-2025-00222.The date of that submission was 23-may-2025.D9 - date returned to mfg: 04-jun-2025.H3: one used sample was received for analysis.Visual inspection was performed, and a cut was observed on the cuff of the set.The deformation of the cut was observed to be irregular in shape, u-like shape.The customer reported issue could be confirmed due to the cut observed in the cuff.The probable cause of the cut is unknown.

• Brand Name: PORTEX 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22575330
• Report Number: 3012307300-2025-08839
• Device Sequence Number: 9457689
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: (01)15019315059544(17)271011(10)4322591
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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 Catalogue Number: 100/189/080
• Device Lot Number: 4322591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female