MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUPERC PERCUTANEOUS DILATION PROCEDURAL KIT WITH SINGLE STAGE DILATOR; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/080
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
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 at the first meeting of the patient and the tracheostomy team admission on the (b)(6) 2023 it was noted that pilot balloon writing was not visible.Tracheostomy tube was inserted on the (b)(6) 2023.It was only in-situ for 15 days.Tracheostomy tube was saved for reporting on the(b)(6) 2023 as patient had tracheostomy change.The event occurred in the hospital.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Device investigation: one used decontaminated device was returned for investigation.Under visual inspection we noticed that the writing on the pilot balloon is rubbing off.It is probable that the failure was caused by customer due to cleaning.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION PROCEDURAL KIT WITH SINGLE STAGE DILATOR
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18643353
• Report Number: 3011237704-2024-00034
• Device Sequence Number: 7317371
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)260714(10)4405216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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 Expiration Date: 07/14/2026
• Device Catalogue Number: 101/563/080
• Device Lot Number: 4405216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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