BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 1641083 · Received March 22, 2010

    Report

    Report Number
    2183502-2010-00094
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMJ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 NURSE WAS SPLASHED WITH A MEDICATION. THE PATIENT WAS RECEIVING THE MEDICATION VIA A DELTOID NEEDLE. DURING THE INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND DRUG SPLASHED ON THE RN'S FACE AND EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK