BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 16514923 · Received March 9, 2023

    Report

    Report Number
    3013886523-2023-00070
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 4, 2023
    Report Date
    May 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): THE BACTISEAL CATHETER (ID 821745) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CONNECTOR WAS VISUALLY INSPECTED; A CRACK WAS NOTED ALONG THE CONNECTOR. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS PROBABLY DUE TO ATYPICAL FORCE WHEN ATTACHING DEVICES, AS NOTED IN THE IFU, FINGER TIGHTEN ONLY WHEN ATTACHING DEVICES.

    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

    UNIQUE DEVICE IDENTIFICATION (UDI): (B)(4). THE HAKIM VALVE (821745) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, THE POSSIBLE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS PROBABLY DUE TO USERS¿ ERROR BY USING ATYPICAL FORCE WHEN CONNECTING DEVICES AND CRACKING THE CONNECTOR, AS NOTED IN THE IFU ¿FINGER TIGHTEN ONLY WHEN ATTACHING DEVICES¿. 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

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821745) WAS PLACED ON (B)(6) 2023. ON (B)(6) 2023 THE CATHETER WAS LEAKING AT THE DISTAL END OF THE CONNECTOR PORT THAT CONNECTS TO THE PATIENT¿S VENTRICULAR CATHETER. THE CONNECTION POINT WAS RETIGHTENED AND RE-SUTURED AT THE PROXIMAL SIDE, HOWEVER, THE LEAK CONTINUED. DUE TO THE INCIDENT, THE VENTRICULAR CATHETER WAS CUT AND RE-SECURED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60914 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown