MAUDE Adverse Event Report: Cordis US Corp CATHETER EXTENSION; Introducer, Catheter

Catalog Number	502102D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, when the 100cm extension tubing was connected to the device and operated, air bubbles formed immediately, rendering the product unusable.There was no reported injury to the patient.The devices were discarded.Therefore, the products are not available for return and evaluation.
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: CATHETER EXTENSION
• Common Device Name: Introducer, Catheter
• Manufacturer (Section D): Cordis US Corp; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): Cordis US Corp.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; +011(786)3138372
• MDR Report Key: 50916060
• Report Number: 9616099-2026-01371
• Device Sequence Number: 17642009
• Product Code: DYB
• UDI-Device Identifier: 10705032064729
• UDI-Public: (01)10705032064729(17)290430(10)18582463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K812231
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 502102D
• Device Lot Number: 18582463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2026
• Supplement Date Received by Manufacturer: 10/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• 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