MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/561/090
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device 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 during a percutaneous dilatation tracheostomy, the tracheostoma could not be inserted with the thin white dilator provided after dilatation with the large dilator, as the inner opening of the insertion aid (violet) was not sufficiently continuous.After inserting the guide wire and white kink protection, the tracheostomy tube with the purple-colored introducer was to be inserted.This was not possible as the white anti-kink protection did not fit through the purple-colored introducer (bottleneck).After removing the bend protection, only the guide wire could be threaded through the introducer, so that the tracheostomy tube could still be inserted.Due to the event, the installation of the tk was somewhat delayed.According to the doctor, there were no problems for the patient (sufficient oxygenation at all times).There was patient involvement, but no adverse events were reported.No further information about the event is available.
Additional Manufacturer Narrative
Investigation summary: the affected device was received for evaluation.A visual test was performed and the issue was confirm.The white protector did not go through the purple introducer.Root cause not established.The failure mode will continue to be monitored and if a trend is identified an investigation will be opened.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BLUPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 19459892
• Report Number: 3011237704-2024-00114
• Device Sequence Number: 20536161
• Product Code: JOH
• UDI-Device Identifier: 15019517103380
• UDI-Public: (01)15019517103380(17)260526(10)4382034
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 07/15/2024

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: 05/26/2026
• Device Catalogue Number: 101/561/090
• Device Lot Number: 4382034
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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