BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-FLO SUBCUTANEOUS SAFETY NEEDLE SETS

    MDR report key: 4938212 · Received July 22, 2015

    Report

    Report Number
    1318360-2015-00003
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    March 18, 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 Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT NOTIFIED INITIAL REPORTER THAT THE NEW SETS ARE INFUSING MEDICINE (GAMMAGARD) FASTER. PATIENT WAS A NEW INFUSION PATIENT (7TH INFUSION) AND USED A DIFFERENT SET PRIOR TO EVENT. PATIENT EXPERIENCED SHORTNESS OF BREATH AND PAUSE INFUSION FOR ONE HOUR. PATIENT COMPLETED INFUSION WITHOUT INCIDENT THEN WENT TO AN EMERGENCY ROOM FOR MONITORING. NO FURTHER PROBLEMS WERE NOTED BY PATIENT. PATIENT INDICATED THAT DOCTOR TOLD PATIENT TO DISCONTINUE USING SET. PATIENT NO LONGER USES THIS PRODUCT. ATTEMPTS TO CONFIRM DOCTOR'S RECOMMENDATION TO DISCONTINUE THE SET, OBTAIN A DISCHARGE PLAN, OR OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475687 HI-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 Other RMS PRECISION FLOW RATE TUBING (MODEL # F275)