MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/856/080
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event : year of event unknown.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 the inner cannula was not clicking or locking into place.There was a patient involvement and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.No damage was found in the sample returned per visual inspection.The cannula was inserted in to the tracheostomy tube in order to verify if the cannula fits correctly.When inserting the cannula into the tracheostomy tube a click was made.The piece was placed upside down to verify that the cannula was well fastened to the tube.The cannula did not disassemble from the tracheostomy tube.The failure mode was not confirmed based on the analysis conducted in the sample provided.A device history record could not be completed as no lot number was received.The failure mode will continue to be monitored and if a trend is identified an investigation will be open.
Additional Manufacturer Narrative
Device evaluation: two samples were returned in unused condition in original packaging.No damage was found during a visual inspection.During the functional testing, the two samples failed the "minimum" ring gauge test.The root cause of the issue was found to be that the od over bumps were out of specification due to flash on the supplier tool.The supplier mold was repaired to remove burr on cavity number two.The supplier updated its inspection test method to align with the icu medical method.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (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: 19610089
• Report Number: 9617604-2024-00545
• Device Sequence Number: 8084926
• Product Code: BTO
• UDI-Device Identifier: 15019517077797
• UDI-Public: (01)15019517077797(17)281011(10)4435054
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 101/856/080
• Device Lot Number: 4435054
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 03/05/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/16/2024; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Patient Sex: Unknown