BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS

    MDR report key: 4938210 · Received July 22, 2015

    Report

    Report Number
    1318360-2015-00002
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    March 29, 2014
    Report Date
    July 21, 2015
    Manufacturer
    REPRO-MED SYSTEMS, INC. (DBA RMS MEDICAL PRODUCTS)
    Product Code
    FPA
    PMA / PMN Number
    K122404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURER'S 2014-2015 COMPLAINT FILE IDENTIFIED THIS EVENT AS REPORTABLE 06/23/2015.

    Description of Event or Problem · 1

    PATIENT WAS USING HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SET, MODEL NUMBER RMS3-2609, WITH RMS' FREEDOM60 SYRINGE INFUSION SYSTEM, MODEL NUMBER F10050. UPON THE COMPLETION OF INFUSION, PATIENT REMOVED ADMINISTRATION SET BUT COULD NOT REMOVE ONE OF THE THREE NEEDLES. THE NEEDLE THE PATIENT COULD NOT REMOVE WAS IN HER THE RIGHT SIDE OF HER ABDOMEN. PATIENT WENT TO THE EMERGENCY ROOM, THE NEEDLE WAS REMOVED, AND PATIENT WAS DISCHARGED THE SAME DAY. EMERGENCY DEPARTMENT DISCHARGE PLAN INDICATES PATIENT WAS ADVISED TO RESUME PRIOR CARE PLAN. THE PATIENT INDICATED THAT THERE WAS ONE OTHER OCCASION IN WHICH SHE HAD DIFFICULTY REMOVING A NEEDLE FROM HER RIGHT ABDOMEN. SUSPECT DEVICE WAS RETURNED AND EVALUATED. DEVICE CONFORMS TO SPECIFICATIONS. THE PATIENT WAS CONTACTED AGAIN ON 06/23/2015. NO ADDITIONAL PROBLEMS WERE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475890 HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS INTRAVASCULAR ADMINISTGRATION SET FPA REPRO-MED SYSTEMS, INC. (DBA RMS MEDICAL PRODUCTS) RMS3-2609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other FREEDOM60 SYRINGE INFUSION SYSTEM