BEUDAMED
    FDA Adverse Event Summary report: N

    INTROCAN SAFETY

    MDR report key: 2010924 · Received February 22, 2011

    Report

    Report Number
    2010924
    Date Received
    February 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 2011
    Manufacturer
    B. BRAUN MEDICAL ,INC.
    Product Code
    FOZ
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    CLINICIAN REPORTED 10 SEPARATE PERIPHERAL INTRAVENOUS (PIV) CATHETER ATTEMPTS ON THE SAME PATIENT. CATHETERS USED WERE A MIX OF 14 MM AND 19 MM CATHETERS INTRODUCED WITH A 26G STYLET AND NEEDLE. THESE ARE NEWLY INTRODUCED SAFETY PIV CATHETERS WHICH HAVE HAVE MANY ASSOCIATED IN-HOUSE REPORTS OF MULTIPLE INSERTION ATTEMPTS. THIS IS THE SECOND MEDWATCH REPORT BY THIS FACILITY. THE MANUFACTURER HAS PROVIDED ADDITIONAL CLINICAL IN-SERVICES BUT MULTIPLE INSERTION ATTEMPTS ARE STILL BEING REPORTED ON OUR INTERNAL RISK MANAGEMENT REPORTING PROGRAM. CATHETERS ARE BEING RETRIEVED, LOGGED, AND SENT TO THE MANUFACTURER FOR ANALYSIS. THE PRIMARY PATIENT POPULATION BEING AFFECTED BY THESE CATHETERS ARE NEONATES LESS THAN 2 MONTHS.====================== MANUFACTURER RESPONSE FOR PERIPHERAL INTRAVENOUS CATHETER, INTROCAN SAFETY======================WE WILL RETURN DEVICES BACK TO MANUFACTURER FOR ANALYSIS AND FEEDBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY CATHETER, INTRAVASCULAR, PERIPHERAL, SAFETY FOZ B. BRAUN MEDICAL ,INC. 4252511-02 0103258272

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA