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

Catalog Number 534620T

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

As reported, material with hair was found inside the sterile packaging of a 6f 100 cm judkins left 4 (jl4) infiniti diagnostic catheter per anvisa notification (b)(4).The packaging had not been opened.There was no reported patient injury.Customer identification was not provided in the anvisa website, and the submitter did not have more information about this case.Additional information was requested; however, could not be obtained.The device will not be returned for evaluation.

Manufacturer Narrative

As reported, material with hair was found inside the sterile packaging of a 6f 100 cm judkins left 4 (jl4) infiniti diagnostic catheter per anvisa notification (b)(4).The packaging had not been opened.There was no reported patient injury.Customer identification was not provided in the anvisa website, and the submitter did not have more information about this case.Without the return of the device or images for analysis, the reported customer event ¿packaging/pouch/box-foreign material in sterile packaging¿ could not be confirmed.It is possible that shipping/handling factors may have compromised the integrity of the sterile packaging.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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18772922
• MDR Text Key: 337076953
• Report Number: 9616099-2024-00062
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.