BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDS3 CLEAR VENT CATH

    MDR report key: 21432801 · Received February 21, 2025

    Report

    Report Number
    3013886523-2025-00041
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 11, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K061568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EDS3 WAS RETURNED FOR EVALUATION: DHR - LOT 7408807, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK . FAILURE ANALYSIS - THE CONNECTOR WAS VISUALLY INSPECTED, BIOLOGICAL DEBRIS WERE NOTED ON THE CONNECTOR AND CRACK AT THE LINK BETWEEN THE EVD CATHETER AND KIT TO COLLECT CSG WAS NOTED. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE IN VIEW OF THE CRACK MARKS ON THE DEVICE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A EDS3 VENTRICULAR CATHETER (ID: 821735) WITH A CRACK LOCATED AT THE LINK BETWEEN THE EVD CATHETER AND THE KIT TO COLLECT CSF, RESULTING IN CSF LEAK. THE CATHETER WAS REPLACED; HOWEVER, IT IS UNKNOWN IF THE SYSTEM WAS TOTALLY OR PARTIALLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634444 EDS3 CLEAR VENT CATH STANDARD EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7408807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown