BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 16158889 · Received January 13, 2023

    Report

    Report Number
    3013886523-2022-00595
    Event Type
    Injury
    Date Received
    January 13, 2023
    Report Date
    January 13, 2023
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K090348
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL CATHETER WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE); THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE DEVICE, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE. 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

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2022. THE CATHETER WAS BROKEN AND LEAKING MINIMAL CEREBROSPINAL FLUID (CSF) NINE DAYS AFTER THE PROCEDURE. THE PATIENT HAD A LITTLE HIGHER BODY TEMPERATURE. THEREFORE, THE CATHETER WAS REMOVED AND MONITORING WAS STOPPED. THE PATIENT RECOVERED AFTER THE TREATMENT AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065347 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG RAYNHAM 821749 6534931 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown