BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA

    MDR report key: 4945396 · Received July 8, 2015

    Report

    Report Number
    4945396
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 14, 2015
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN 3 MALFUNCTIONS OF NEEDLES IN LAST 2 WEEKS. THE MALFUNCTION WAS THAT, WHEN PULLING OUT THE STYLET, THE END CAP FELL OFF AND THERE WAS BLOOD DRIPPING. THE THIRD NEEDLE WAS STUCK IN THE TUBING AND WHEN PRESSURE WAS RELEASED, THE NEEDLE CAME THROUGH THE TUBING. THE IV NEEDED TO BE RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443620 SAF-T-INTIMA CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 2 FOZ BD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *