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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, there was a crack at the luer lock connection of a 6 f inifiniti judkins left (jl) 4 100 cm diagnostic catheter.The device was not used in the patient and there was no reported patient injury.The device was removed from the packaging and was flushed with saline when it was noticed that there was leaking from syringe.The device never entered patient.The device was stored and prepped as per the instructions for use (ifu).The user is trained to the device.The procedure was completed by replacing the catheter with an unknown catheter.Additional information was requested but not provided.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, there was a crack at the luer lock connection of a 6 f infiniti judkins left (jl) 4 100cm diagnostic catheter.The device was not used in the patient and there was no reported patient injury.The device was removed from the packaging and was flushed with saline when it was noticed that there was leaking from syringe.The device never entered patient.The device was stored and prepped as per the instructions for use (ifu).The user is trained to the device.The procedure was completed by replacing the catheter with an unknown catheter.Additional information was requested but not provided.One non-sterile ¿cath f4 inf jl 4 100cm¿ unit was received for analysis.During visual inspection, no apparent damages, leakages, or cracks were observed on the hub and body of the catheter.Dimensional analysis was performed to review and verify the measurement of the thread outer diameter and found within specification.For functional analysis, the catheter was flushed and a leak flowing through a crack on the hub was seen.For microscopic analysis, an amplified image of the hub was taken with a vision system.The crack located on the top of the hub was observed and it extends along the luer hub body.Sem analysis was performed on the crack and it presented evidence of fatigue striations and plastic deformation.No other anomalies were observed during sem analysis.The customer¿s complaint, reported as ¿luer hub-cracked,¿ was confirmed during functional testing, where evidence of a crack was found.The fatigue striations and plastic deformations found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the plastic material was subjected to a tensile force that exceeded the hub component material¿s yield strength prior to the damage.However, the source of the excessive force cannot be determined 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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information, 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 CORPORATION; 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 ; 7863138372
• MDR Report Key: 21175680
• Report Number: 9616099-2025-00077
• Device Sequence Number: 8537453
• Product Code: DQO
• UDI-Device Identifier: 10705032014601
• UDI-Public: (01)10705032014601(17)270331(10)18304346
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Model Number: N/A
• Device Catalogue Number: 538420
• Device Lot Number: 18304346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2025
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• 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
• Patient Sex: Unknown