BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 11701378 · Received April 21, 2021

    Report

    Report Number
    3013886523-2021-00173
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 20, 2021
    Report Date
    June 18, 2021
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K090348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 821749 WITH LOT 4561688 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE RETURNED DEVICES WERE VISUALLY INSPECTED; NO DEFECTS WERE NOTED WITH THE CATHETER. THE RED LEUR LOCK CAP WITH THE FEMALE CONNECTOR WERE RETURNED ATTACHED, THESE HAVE BEEN SCREWED TOGETHER SO TIGHTLY THAT IT IS NOT POSSIBLE TO SEPARATE THEM, WHITE CLOUDY STRESS MARKS ON THE CONNECTORS WERE NOTED THIS IS DUE TO OVER TIGHTENING THE TWO PARTS. THE DEVICES WERE LEAK TESTED, AND NO LEAKS NOTED. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS NO LEAKAGE WAS NOTED WITH THE RETURNED DEVICES. THE ROOT CAUSE FOR THE STRESS MARKS NOTED IN THE CONNECTORS IS DUE TO OVER TIGHTENING, AS NOTED IN THE IFU FINGER TIGHTEN ONLY. THE POSSIBLE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS PROBABLY DUE TO USERS ERROR BY USING ATYPICAL FORCE WHEN ATTACHING THE CONNECTORS. AS NOTED IN THE IFU ¿FINGER TIGHTEN ONLY WHEN ATTACHING DEVICES¿. THE REPORTED INCIDENT WAS NOT DUPLICATED.

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED A LEAKING VENTRICULAR CATHETER. THE CODMAN BACTISEAL EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED IN A PATIENT ON (B)(6) 2021. DURING THE PROCEDURE, THE WHITE TIP OF THE DEVICE AT THE CONNECTING POINT WAS LEAKING CEREBRAL SPINAL FLUID. THE PHYSICIAN CHANGED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS A ONE-HOUR DELAY IN THE PROCEDURE, BUT NO ADVERSE CONSEQUENCES DUE TO THE LEAKING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600888 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG RAYNHAM 4561688

    Patients

    Seq Age Sex Outcome Treatment
    1