BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC

    MDR report key: 1081158 · Received July 9, 2008

    Report

    Report Number
    1081158
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    April 7, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CALLED RN TO ROOM. BARD MINILOC HUBER NEEDLE (FEMALE END OF LUER LOCK) BROKE OFF REST OF LINE WITH NEEDLE INTACT. PATIENT WAS IMMEDIATELY RE-ACCESSED. LINE FLUSHED WELL WITH BLOOD DRAWN BACK. MOM AT BEDSIDE DURING PROCEDURE. MINILOC NEEDLE EXAMINED BY CLINICAL ENGINEERING. APPEARS TUBING CAME UNGLUED FROM LUER LOCK END. THERE ARE ON-GOING ISSUES WITH MINILOC NEEDLES. BARD HAS VERBALLY SAID THEY CHANGED THE MANUFACTURING GLUING PROCESS IN APRIL 2008, AND SENT US ALL NEW NEEDLES TO REPLACE OLD STOCK. REPLACEMENT BEGAN IN INVENTORY CONTROL ON 5-8-08====================== MANUFACTURER RESPONSE FOR SAFETY INFUSION SET, MINILOC======================BARD HAS SAID THEY CHANGED THE MANUFACTURING PROCEDURE IN APRIL 2008. WE CHANGED OUT ALL OUR LOTS AND HAVE NOT HAD A PROBLEM SINCE WE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILOC INFUSION SET, HUBER NEEDLE FMI BARD ACCESS SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR