MAUDE Adverse Event Report: CORDIS US CORP INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	534620T
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	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported via (b)(6) notification (b)(4), a strand of hair was found inside the sterile packaging of a 6f 100 cm judkins left (jl4) infiniti diagnostic catheter which was not opened.There was no reported patient injury.Additional event details were requested; however, not provided.The device was not returned for evaluation as anticipated.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a strand of hair was found inside the sterile packaging of a 6f 100 cm judkins left (jl4) infiniti diagnostic catheter which was not opened.There was no reported patient injury.Additional event details were requested; however, not provided.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18160411 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿packaging/pouch/box foreign material in sterile package moveable particle¿" could not be evaluated.With the limited information provided, without the return of the device, and with no images of the packaging/foreign material, the cause of the reported event could not be determined.Unspecified handling or storage factors may have contributed to the reported issue.Users should inspect for any signs of damage prior to and during use.Any product with damage should not be used.Based on the information available for review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 21881460
• Report Number: 9616099-2025-00684
• Device Sequence Number: 15638970
• Product Code: DQO
• UDI-Device Identifier: 10705032014182
• UDI-Public: (01)10705032014182(17)251031(10)18160411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 05/22/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 534620T
• Device Lot Number: 18160411
• Was Device Available for Evaluation?: No
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2022
• 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