BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPODERMIC NEEDLE-PRO AND NEEDLE WITH NEEDLE PROTECTION DEVICE

    MDR report key: 1872136 · Received October 11, 2010

    Report

    Report Number
    2183502-2010-00439
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 7, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    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 F/U REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED A NURSE WAS SPLASHED WITH A MEDICATION. THE PT WAS RECEIVING THE MEDICATION VIA A DELTOID NEEDLE. DURING THE INJECTION THE NURSE ENCOUNTERED RESISTANCE; IN RESPONSE SHE DEPRESSED THE PLUNGER WITH GREATER FORCE. IT WAS REPORTED THAT THE PT REC'D A PARTIAL DOSE AND REMAINDER SPLASHED BACK INTO THE NURSE'S 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 CAZ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK