BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 2183541 · Received July 27, 2011

    Report

    Report Number
    2183541
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    B. BRAUN MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    EVENT OCCURRED WHILE INSERTING ONE OF THE NEW B. BRAUN CATHETERS. WHEN RETRACTING NEEDLE BACK, THE SMALL SQUARE PIECE THAT PROTECTS THE NEEDLE DISCONNECTED INTO THE HUB OF THE CATHETER, PREVENTING BLOOD FLOW. BLOOD WAS OBVIOUS IN THE SHAFT OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY IV CATHETER FOZ B. BRAUN MEDICAL * 1C27258371

    Patients

    Seq Age Sex Outcome Treatment
    1 *