MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUE LINE ULTRA SELECT CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/810/085CZ
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when deflating the cannula cuffs to remove them, there was a small amount of liquid in the syringe used to deflate the cuff, casting doubt on the airtightness of the cuff.There was patient involvement with no visible injuries, it was only mentioned that the patient was "more cluttered".The patient did not need further treatment as a result of this incident.
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.
Additional Manufacturer Narrative
Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.Tracheostomy tube inflation system is dedicated for inflation of cuff by air.Therefore, it shall be perfectly leak proof.There are only two possible reasons for a fluid inside inflation system - inflation system leak (e.G.Fluid can get into inflation system through cuff tear) or incorrect practice during use which do not respect instructions for use (e.G.Cleaning of inflation system by a fluid/inflation line flushed by a liquid instead of suction line by error/etc.).Without the sample we are unable to determine the true root cause of this issue.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.No trend of confirmed complaints in relation to this issue was identified.

• Brand Name: PORTEX BLUE LINE ULTRA SELECT CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19061006
• Report Number: 3011237704-2024-00081
• Device Sequence Number: 17792872
• Product Code: BTO
• UDI-Device Identifier: 15019517076318
• UDI-Public: (01)15019517076318(17)280209(10)4306011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: 101/810/085CZ
• Device Lot Number: 4306011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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