BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV SCIG 36" 27G 9MM, SUB-320

    MDR report key: 8650904 · Received May 28, 2019

    Report

    Report Number
    MW5086966
    Event Type
    Injury
    Date Received
    May 28, 2019
    Report Date
    May 16, 2019
    Manufacturer
    REPRO-MED SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS SENT RMS NEEDLES INSTEAD OF EMED (POSSIBLY BECAUSE OF STOCK ISSUE). PT STATED THERE WAS SOME BLOOD DURING DRAWBACK, AND A LITTLE LEAKING CAUSING SOME LOCAL REDNESS. WHEN TRYING TO RE-INSERT NEEDLE. RPH ADVISED PT TO USE DIFFERENT NEEDLE SET WHEN THIS OCCURS. PT UNDERSTOOD. NO MISSED DOSES OCCURRED. NO OTHER INFO KNOWN. REPORTED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437984 IV SCIG 36" 27G 9MM, SUB-320 SET, ADMINISTRATION, INTRAVASCULAR FPA REPRO-MED SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1