BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 3952667 · Received July 17, 2014

    Report

    Report Number
    2523676-2014-00279
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 2, 2014
    Manufacturer
    B. BRAUN MELSUNGEN A
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE HAD UNSUCCESSFUL ATTEMPT TO START IV, THEN ATTEMPTED TO RECAP THE CATHETER AND NEEDLE TOGETHER IN THE PROTECTIVE SLEEVE AND HAD A NEEDLE STICK. NO SAMPLE SAVED. SALES REP HAS PROVIDED RE IN-SERVICES FOR THE FACILITY SEVERAL TIMES. INCIDENT OCCURRED WITH REF # (B)(4), LOT # UNKNOWN. MFR - 9610825-2014-00279.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420115 INTROCAN SAFETY I.V. SAFETY CATHETER FOZ B. BRAUN MELSUNGEN A NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK