BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 22202033 · Received June 13, 2025

    Report

    Report Number
    3013886523-2025-00150
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 22, 2025
    Report Date
    October 17, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515593
    PMA / PMN Number
    K233448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 D8 D9 G6 H1 H2 H3 H4 H6 H11 THE BACTISEAL EVD CATHETER (821745) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 821745 WITH LOT 7456814, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CONNECTOR WAS VISUALLY INSPECTED, AND FRACTURES WAS NOTED IN ONE OF THE SIDES. THE COMPLAINT WAS CONFIRMED. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO EXCESSIVE FORCE USED DURING THE MANIPULATION OF THE CONNECTOR.

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00149. A FACILITY REPORTED THE WHITE CONNECTORS OF THE EVD SET WERE DAMAGED POST-SURGERY, CAUSING FLUID LEAKAGE. THE DAMAGED CONNECTORS WERE REPLACED AFTER THE INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353006 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7456814 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown