BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3841299 · Received May 20, 2014

    Report

    Report Number
    2523676-2014-00195
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    December 28, 2013
    Report Date
    April 25, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS TWO NURSES WERE DRAWING BLOOD FROM A BABY. THE NEEDLE WAS PULLED OUT OF THE BABY AND THE SAFETY MECHANISM ACTIVATED BUT IT DID NOT FULLY COVER THE NEEDLE. THE RN WAS PUNCTURED BY A CONTAMINATED NEEDLE. REF MFR REPORT 2523676-2014-00195.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299306 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG. NA 3D12258391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK