BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDS3 CLEAR VENT CATH

    MDR report key: 22097074 · Received May 28, 2025

    Report

    Report Number
    3013886523-2025-00124
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 2, 2025
    Report Date
    July 31, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518372
    PMA / PMN Number
    K061568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS. ADDITIONAL INFORMATION PROVIDED: THE EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WAS REPLACED; HOWEVER, THE VENTRICULAR CATHETER (ID 821735) WAS NOT REPLACED. THE EVENT LED TO LESS THAN 30 MINUTES SURGICAL DELAY.

    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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H3, H6, H11. THE EVD (CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM - ID (B)(6)) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO A PROBLEM IN THE CONNECTION BETWEEN THE PATIENT LINE AND THE EDS SYSTEM. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A NEUROSURGERY RESIDENT WAS FLUSHING PATIENT'S EVD (CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM - ID 821735). THE RESIDENT AND THE BEDSIDE RN NOTICED THE CODMAN TUBING HAD A LEAK IN IT. THERE WAS NO DRAINAGE/ LEAKAGE NOTICED PRIOR TO THIS INCIDENT AND NO DRAINAGE NOTED ON SHEETS. A NEW CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM WAS PLACED.NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AFTER SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333002 EDS3 CLEAR VENT CATH STANDARD EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780518372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male