BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO HYPODERMIC NEEDLE-PRO SYRINGE

    MDR report key: 2954292 · Received January 9, 2013

    Report

    Report Number
    2183502-2012-00665
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FMJ
    PMA / PMN Number
    K923127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED DURING AN INJECTION VIA THE DEVICE THE NEEDLE BECAME DETACHED FROM THE SYRINGE. THE NURSE REMOVED THE BROKEN NEEDLE. NO NEEDLESTICK TOOK PLACE. THERE WAS NO PATIENT OR CLINICIAN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11328 JELCO HYPODERMIC NEEDLE-PRO SYRINGE FMJ SMITHS MEDICAL MD, INC. NA 2357313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK