BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 20212942 · Received September 13, 2024

    Report

    Report Number
    3013886523-2024-00284
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 23, 2024
    Report Date
    April 2, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K090348
    Adverse Event
    Yes
    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

    THIS FOLLOW-UP IS TO MAKE A CORRECTION IN THE FOLLOW-UP SENT ON 12/06/2024: G3 - AWARENESS DATE IS 11/25/2024 (NOT 10/25/2024).

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER (ID 821749) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): THE PRODUCT CODE 82-1749 WITH LOT 7361173, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. ALL FINISHED GOODS TEST RESULTS, INCLUDING ENDOTOXIN SATISFACTORILY MET THE REQUIREMENTS. FAILURE ANALYSIS: THE CATHETER WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. NO TESTS COULD BE PERFORMED AS THE CATHETER IS VERY SHORT. ROOT CAUSE ANALYSIS: NO ROOT CAUSE COULD BE DETERMINED AS THE CATHETER IS VERY SHORT. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO IMPROPER HANDLING OF THE DEVICE OR COULD BE DUE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PHYSICIAN FOUND A MINIMAL AMOUNT OF CEREBROSPINAL FLUID (CSF) LEAKING AT THE END OF THE CATHETER, WHERE IT WAS CONNECTED TO THE LURE-CONNECTOR. THE CATHETER WAS REMOVED ON THE SAME DAY AND A SMALL HOLE WAS FOUND AT THE END OF THE CATHETER. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION-RELATED FEVER WITH A TEMPERATURE OF 39°C. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, IT WAS NOT PROVIDED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207975 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7361173 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention