BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD DRAW HYPODERMIC NEEDLE-PRO DEVICE

    MDR report key: 1610948 · Received February 12, 2010

    Report

    Report Number
    2183502-2010-00026
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 11, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMJ
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED A TECHNICIAN WAS SPLASHED WITH A BLOOD. BLOOD WAS BEING TRANSFERRED FROM A SYRINGE TO A BLOOD CULTURE BOTTLE USING THIS DEVICE. THE NEEDLE BROKE OFF WHERE THE NEEDLE IS CONNECTED TO THE PLASTIC. IT CAUSED BLOOD TO SPLASH IN THE TECH'S FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD DRAW HYPODERMIC NEEDLE-PRO DEVICE FMJ - NEEDLE, HYPODERMIC FMJ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK