BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH VENTRICULAR CORDIS

    MDR report key: 9593208 · Received January 9, 2020

    Report

    Report Number
    9593208
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 3, 2020
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ICP MONITOR CATHETER TIP BROKE OFF DURING REMOVAL. RETURN TO OPERATING ROOM ON (B)(6) 2019 WITH RETAINED TIP EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35983 CATH VENTRICULAR CORDIS VENTRICULAR CATHETER JXG INTEGRA LIFE SCIENCES 901302 901-902

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention