BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY

    MDR report key: 1403432 · Received June 4, 2009

    Report

    Report Number
    1403432
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    June 4, 2009
    Report Date
    June 4, 2009
    Manufacturer
    BRAUN MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE SAFETY NEEDLE COVER WAS NOT PRESENT WHEN THE NEEDLE WAS REMOVED FROM THE ANGIOCATH AFTER INSERTION. NURSE EXAMINED CLOSELY FOR SIGNS OF THE CAP AND FOUND NONE. X-RAY TO PATIENT'S FOREARM REVEALED NO FOREIGN OBJECT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTROCAN SAFETY CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BRAUN MEDICAL INC. * 9B12258302

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR