BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 21857955 · Received April 17, 2025

    Report

    Report Number
    3013886523-2025-00076
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 5, 2025
    Report Date
    June 13, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K233448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11 THE BACTISEAL CATHETER (ID 821749) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 821749 WITH LOT 7365500 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED. THE LEAK TEST WAS PERFORMED; NO LEAKS WERE NOTED. THE COMPLAINT COULD NOT BE CONFIRMED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED AS NO DEFECTS COULD BE FOUND WITH THE CATHETER. A POSSIBLE ROOT CAUSE FOR THE REPORTED ISSUE COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    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

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS LEAKING A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) AT THE SIDE WALL OF THE END PORTION OF THE CATHETER. THE EVENT HAPPENED DURING IMPLANTATION (BEFORE IMPLANTATION SITE CLOSURE). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO ADVERSE CONSEQUENCES REPORTED, AND THE EVENT DID NOT LEAD TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777023 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7365500 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown