BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD POWER GLIDE MIDLINE CATHETER M120101

    MDR report key: 3929721 · Received June 6, 2014

    Report

    Report Number
    3929721
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BARD
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF MID LINE CATHETER RESISTANCE WAS MET DURING INSERTION PROCEDURE. ATTEMPTS WERE MADE TO SAFELY ADVANCE AND REMOVE THE CATHETER. THE NEEDLE AND GUIDE WIRE AND A PORTION OF THE CATHETER WERE REMOVED. IT WAS NOTED THAT A PORTION OF THE CATHETER WAS SHEARED OFF UNDER THE SKIN. THIS REQUIRED SURGICAL INTERVENTION TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331048 BARD POWER GLIDE MIDLINE CATHETER M120101 MIDLINE CATHETER FOZ BARD M120101 REYB1766

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention