BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO NEEDLE-PRO 1 ML TB TESTING SYRINGE

    MDR report key: 2082534 · Received April 28, 2011

    Report

    Report Number
    2183502-2011-00385
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 27, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    PMA / PMN Number
    K011925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PT WAS SPLASHED WITH A MEDICATION. THE PT WAS RECEIVING THE MEDICATION VIA A TB NEEDLE. DURING THE INJECTION, THE NEEDLE BECAME DETACHED FROM THE SYRINGE AND DRUG SPLASHED IN THE PT'S EYE. NURSE RINSED THOROUGHLY AND FOLLOWED HER CLINIC PROTOCOL FOR MEDICATION EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO NEEDLE-PRO 1 ML TB TESTING SYRINGE FMI - NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK