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

Catalog Number	101/870/075CZ
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 writing on the tracheostomy tube pilot balloon rubbed off during use due to cleaning.Patient had initial tracheostomy tube inserted; however, patient self-decannulated.The event took place at the hospital during the routine trach team rounds.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one used decontaminated sample was returned for investigation without its original packaging.Under visual inspection we noticed that the writing on the pilot balloon was rubbing off, confirming the customer's complaint.During manufacturing each pilot balloon is 100% visual checked.Detection mechanisms are in place, and it is improbable that the part with the writing rubbed off would pass through this inspection.It is probable that the failure was caused by the customer due to cleaning (e.G.Excessive force during cleaning, aggressive cleaner).No trend of confirmed complaints in relation with this issue was identified.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX SUCTIONAID BLUSELECT TRACHEOSTOMY TUBE, CUFFED
• 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: 19360663
• Report Number: 3011237704-2024-00107
• Device Sequence Number: 12347769
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: (01)15019517076219
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 101/870/075CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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