BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3271803 · Received July 25, 2013

    Report

    Report Number
    2523676-2013-00091
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REF # 4251652-02, LOT #2A12258302, REPORTS PASSIVE SAFETY CLIP DID NOT FULLY ENGAGE. REF MFR REPORT 9610825-2013-00091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349004 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN AG NA 2A12258302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other