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

Catalog Number	101/563/080
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 a difficulty inserting gauge stage dilator, increased flexibility and upon removal of the gauge stage dilator noticed damage to the tip.The single stage dilator felt more flexible than usual, also impeding the procedure.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.One device sample was received for evaluation.Under visual inspection it was confirmed that the pre-dilator was damaged, but no split is visible.The damage most probably occurred during use due to the properties of the material.The pre-dilator is made from flexible material.The pre-dilator is soft and flexible, which is typical for this part.The complaint was confirmed, and the root cause was unknown.A device history record (dhr) review could not be performed as the lot number was unknown.

• 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: 20408252
• Report Number: 3011237704-2024-00215
• Device Sequence Number: 19677839
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 101/563/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/03/2024
• 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