BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN.

    MDR report key: 6942559 · Received October 11, 2017

    Report

    Report Number
    1710034-2017-00261
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7080821 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 1, FROM MARCH 25, 2017 THRU MARCH 30, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS (B)(4), IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. THE DEFECT OF NEEDLE STICK INJURY, AS STATED IN THE SUBJECT OF THE PIR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN. DID NOT FUNCTION PROPERLY, CAUSING A DIRTY NEEDLE STICK ON THE FINGER OF A HEALTHCARE WORKER. THIS INCIDENT WAS REPORTED THROUGH HEALTH AND SAFETY AT THE WORKPLACE AND MEDICAL EXAMS AND EMERGENCY ASSESSMENT WAS PERFORMED BUT THERE WERE NO SPECIFIC LABS OR TESTS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719488 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7080821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention