BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS

    MDR report key: 4938231 · Received July 22, 2015

    Report

    Report Number
    1318360-2015-00001
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    March 8, 2015
    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 Location
    CA, US
    Reporter Occupation
    OTHER

    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 RMS4-2609, 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 FOUR NEEDLES. THE NEEDLE THE PATIENT COULD NOT REMOVE WAS IN HER THIGH. PATIENT WENT TO THE EMERGENCY ROOM AND THE NEEDLE WAS REMOVED BY THE TRIAGE NURSE. PATIENT WAS NOT EVALUATED BY A PHYSICIAN AND DID NOT RECEIVE A MEDICAL REPORT. THE PATIENT INDICATED THAT THERE WERE 3 OR 4 OTHER OCCASIONS DURING THE PREVIOUS YEAR IN WHICH SHE HAD DIFFICULTY REMOVING A NEEDLE BUT THIS WAS THE FIRST TIME SHE SOUGHT MEDICAL ATTENTION FOR THE PROBLEM. THE PATIENT WAS CONTACTED AGAIN ON (B)(6) 2015. PATIENT INDICATED THAT SHE CONTINUED WITH HER ORIGINAL TREATMENT FOR APPROXIMATELY TWO MONTHS AND EXPERIENCED NO ADDITIONAL PROBLEMS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475916 HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS INTRAVASCULAR ADMINISTRATION SET FPA REPRO-MED SYSTEMS, INC. (DBA RMS MEDICAL PRODUCTS) RMS4-2609 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other FREEDOM60 SYRINGE INFUSION SYSTEM