BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BEVD 1.9MM CAT SET

    MDR report key: 24469594 · Received February 27, 2026

    Report

    Report Number
    3013886523-2026-00043
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 3, 2026
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780518440
    PMA / PMN Number
    K233448
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. BACTISEAL CATHETER (ID 821749) WAS NOT RETURNED FOR EVALUATION (NOT AVAILABLE FOR RETURN AS PER CUSTOMER); THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORDS (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

    A FACILITY REPORTED A BACTISEAL CATHETER (ID 821749) WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, A LEAKAGE WAS OBSERVED AT THE CATHETER INTERFACE, AND IT WAS REMOVED, NOT REPLACED. THE PATIENT'S CONDITION REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475898 CODMAN BEVD 1.9MM CAT SET BACTISEAL JXG INTEGRA LIFESCIENCES MANSFIELD 7565442 10381780518440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention