BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA

    MDR report key: 6188908 · Received December 20, 2016

    Report

    Report Number
    6188908
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 1, 2016
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS STARTING A NEW IV ON PATIENT, USING THE BUTTERFLY. SHE GOT INTO THE VEIN AND WITHDREW THE NEEDLE. SHE WENT TO FLUSH IT WITH SALINE, AND BLOOD AND SALINE SPRAYED OUT OF THE IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841287 SAF-T-INTIMA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD 6208768

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR