MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401645M
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon unpacking, the 6f 45cm brite tip sheath introducer was found defected.Per the two images provided, there appears to be a dark-colored, non-moveable particle on the cannula.There were no reports of patient injury.The device was not used.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, upon unpacking, the 6f 45cm brite tip sheath introducer was found defective.Per the two images provided, there appears to be a dark-colored, non-moveable particle on the cannula.There were no reports of patient injury.The device was not used.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A sterile unit of catheter si brite tip 6f 45cm str was received coiled inside a clear plastic bag and evaluated while sealed in its original pouch.Visual inspection revealed a black inclusion embedded in the cannula, with no other visible damage or anomalies observed.The kinked/bent conditions noted on the unit were attributed to handling during shipment from the decontamination laboratory to the product analysis laboratory and were not considered part of the product analysis.Dimensional analysis was conducted to assess the inclusion embedded in the cannula and the results were within specification.The presence of the inclusion was confirmed; however, based on the work instruction used during manufacturing for contamination assessment, the unit met quality control requirements and passed inspection at the time of production.The defect found is part of the manufacturing process, however, it is within quality control requirements.The reported ¿catheter sheath introducer (csi)- foreign material¿ was observed during the product evaluation.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a dry, dark, cool place.Do not use if package is open or damaged.¿ based on the product analysis, the inclusion was found to be part of the manufacturing process and within specification.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21921431
• Report Number: 9616099-2025-00723
• Device Sequence Number: 8720266
• Product Code: DYB
• UDI-Device Identifier: 10705032000260
• UDI-Public: (01)10705032000260(17)270531(10)18327044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2025

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: 401645M
• Device Lot Number: 18327044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 07/14/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/13/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown