BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 19143553 · Received April 19, 2024

    Report

    Report Number
    3013886523-2024-00117
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 2, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K090348
    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

    THE BACTISEAL CATHETER (ID 821749) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CLEARLY DETERMINED BUT COULD BE DUE TO THE THREAD ON SCREW HAS WORN DOWN DUE TO OVER TIGHTENING. 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.

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER (ID 821749) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- THE PRODUCT CODE 82-1749 WITH LOT 7298250, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CATHETERS WERE VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE CATHETER WAS LEAK; NO LEAKS WERE NOTED. ROOT CAUSE- NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY LEAK ISSUE WITH THE CATHETER AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE COULD BE DUE TO THE THREAD ON SCREW HAS WORN DOWN DUE TO OVER TIGHTENING OR COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2024. FOUR DAYS AFTER THE DEVICE WAS IMPLANTED, IT WAS FOUND THAT CEREBROSPINAL FLUID (CSF) WAS LEAKING AT THE CONNECTION PART OF CATHETER'S LUER FITTING AND EXTERNAL DRAINAGE BAG. THE CATHETER WAS REMOVED AND REPLACED ON (B)(6) 2024. THE PATIENT DID NOT EXPERIENCE SIGNS AND SYMPTOMS DUE TO CSF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035394 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7298250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown