BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 15001126 · Received July 13, 2022

    Report

    Report Number
    3013886523-2022-00323
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 28, 2022
    Report Date
    September 7, 2022
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K090348
    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

    THE BACTISEAL CATHETER (ID 821749) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 5847395, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CATHETER WAS VISUALLY INSPECTED; 2 HOLES/CUTS/TEARS IN THE CONNECTING END OF THE CATHETER WERE NOTED. COMPLAINT CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO A HANDLING OR A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER, AS NOTED IN THE "IFU" SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS LEAKING MINIMAL CEREBROSPINAL FLUID (CSF) DURING THE PROCEDURE. THE LEAKAGE WAS IN THE WHITE TIP OF THE DEVICE AT THE CONNECTING POINT. THE ISSUE WAS DETECTED BEFORE IMPLANTATION SITE CLOSURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AND 1 HOUR DELAY WAS NOTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700232 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG RAYNHAM 821749 5847395 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown