BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 GA 1.00 IN INSYTE AUTOGUARD

    MDR report key: 2112411 · Received May 30, 2011

    Report

    Report Number
    2112411
    Event Type
    Malfunction
    Date Received
    May 30, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN WAS STARTING A PIV ON A PATIENT. THE INSYTE BARREL FAILED TO RETRACT AND HAD TO BE PUSHED BACK INTO THE INSTRUMENT. IT WOULD NOT COMPLETELY RETRACT. WE HAVE BEEN HAVING PROBLEMS WITH THE SPRING MECHANISM ON THESE UNITS AS THEY POP OUT WITHOUT PRESSURE ON THE SWITCH. WHICH CAUSED REBOUND AND A NEEDLESTICK. NEEDLES ARE ALSO PIERCING THE CANNULAS ONCE INSERTED, AS IF THE NEEDLE WERE CROOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 22 GA 1.00 IN INSYTE AUTOGUARD 22 GA 1.00 IN INSYTE AUTOGUARD FOZ BD NA 0315143

    Patients

    Seq Age Sex Outcome Treatment
    1 *