BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 17818545 · Received September 26, 2023

    Report

    Report Number
    3013886523-2023-00334
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    September 2, 2023
    Report Date
    October 26, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K090348
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BACTISEAL EVD CATHETER (ID 821749) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT WAS DISCARDED AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE 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 CATHETER. 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.

    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 FACILITY REPORTED THAT AFTER A BACTISEAL EVD CATHETER (ID (B)(6)) WAS IMPLANTED, THERE WAS BLOOD LEAKING FROM PUNCTURE CHANNEL WHERE THE CATHETER WAS INSERTED IN THE BRAIN. THE CATHETER WAS IMPLANTED ON (B)(6) 2023 AND EXPLANTED ON (B)(6) 2023. THE CATHETER WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776768 CODMAN BEVD 1.9MM CAT SET BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7028126 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown