BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3841296 · Received May 5, 2014

    Report

    Report Number
    2523676-2014-00151
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 25, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: INTROCAN SAFETY, UNKNOWN LOT NUMBER. EVENT DESCRIPTION: "AFTER STARTING THE IV, SHE PLACED THE NEEDLE PORTION OF IV CATHETER IN 4X4'S, AND WHEN SHE PICKED UP THE 4X4'S THAT CONTAINED THE REMNANTS OF THE IV CATHETER, SHE FELT SOMETHING SHARP GO THROUGH HER GLOVE." "NEEDLE STICK HAPPENED ON (B)(6) 2014. SHE REPORTS THAT SHE STARTED THE IV ON THE PATIENT WITH A #20G X 1" BRAUN INTROCAN SAFETY DEVICE." NO SAMPLE. REF MFR REPORT 9610825-2014-00151.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268095 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK