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

Catalog Number	101/563/070
Medical Device Problem Codes	Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
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 there was difficulty inserting gauge stage dilator, increased flexibility and upon removal of the dilator there was damage to the tip.The single stage dilator felt more flexible than usual, also impeding the procedure.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one unused sample in its original packaging was received for investigation.The customer is claiming that the pre-dilator is too soft and the tip is damaged.Pre-dilator is made from flexible material.The pre-dilator is soft, flexible which is typical for this part.Unused dilators in smiths medical czech republic production were randomly checked and no abnormality was observed.The flash on the tip of the pre-dilator is visible.The size of the flash is 0,278mm (measured on the shadowgraph) which is acceptable."external flash should not exceed 0,38mm." complaint history was checked and there has not been any similar customer complaint raised against product made by smiths medical czech republic.Based on that this claim is isolated incident - material flexibility of pre-dilators is considered to be well accepted by rest of market.And no complaint for flashes on the tip has been raised.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: PORTEX PERCUTANEOUS DILATION PROCEDURAL KIT
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20408408
• Report Number: 3011237704-2024-00216
• Device Sequence Number: 20438766
• Product Code: BTO
• UDI-Device Identifier: 15019517103403
• UDI-Public: (01)15019517103403(17)260606(10)4390738
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 06/06/2026
• Device Catalogue Number: 101/563/070
• Device Lot Number: 4390738
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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