BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 17405458 · Received July 27, 2023

    Report

    Report Number
    3013886523-2023-00238
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 5, 2023
    Report Date
    August 10, 2023
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K090348
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6 & H10. FAILURE ANALYSIS - THE BACTISEAL CATHETER (ID (B)(6)) WAS NOT RETURNED FOR EVALUATION BUT A PHOTO WAS PROVIDED AND CONFIRM THE BROKEN CATHETER. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ¿CATHETER BROKE IN TWO.¿ REPORTED BY THE CUSTOMER, COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE CATHETER, AS NOTED IN THE IFU SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A NURSE REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2023 AND SEVERAL DAYS AFTER IMPLANTATION, THE CATHETER BROKE INTO TWO SHORTLY AFTER THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN. THE CATHETER WAS REMOVED ON (B)(6) 2023 AND ALL PIECES WERE RECOVERED. THE PATIENT STATUS IS UNKNOWN, AND THE CATHETER WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232400 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG RAYNHAM 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown