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

Catalog Number	100/189/065
Medical Device Problem Codes	Difficult to Remove (1528); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that upon extubation, it was found that the endotracheal tube (ett) was stuck on something and could not be pulled out.This occurred during 6 different extubations that were known.For 2 of these extubations, a bronchoscope was used which confirmed no secretions or anything else was attached to the ett.Examination of the ett showed that the design of the tube may be the issue.The top portion of the cuff had a stiff protruding edge when deflated and may have got caught on the vocal cords.The doctor discovered the problem when trying to extubate the patient.Patient intubated for several hours overnight with the product in place.Intubation was not necessary.Medical intervention was required as a bronchoscope was required to extubate the patient due to the excessive force required to remove the ett, to ensure no trauma.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
No device or device photo was returned for investigation.Functional and visual testing could not be performed and no confirmation due to no device returned.Due to this, no root cause was determined.The device history review of the reported lot number found no non-conformities during the manufacturing process.

• Brand Name: PORTEX SACETT CUFFED 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: 19982144
• Report Number: 9617604-2024-00651
• Device Sequence Number: 20926514
• Product Code: BTR
• UDI-Device Identifier: 15019315059513
• UDI-Public: (01)15019315059513(17)280315(10)4381326
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 100/189/065
• Device Lot Number: 4381326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown