BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING FREEDOM 60 SYR INF

    MDR report key: 8522923 · Received April 16, 2019

    Report

    Report Number
    MW5085922
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 5, 2019
    Manufacturer
    REPRO-MED SYSTEMS, INC. / RMS MEDICAL PRODUCTS
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PROVIDED DETAILS REGARDING 2 GM INFUSION AT MD OFFICE ON (B)(6) 2019, STATING THAT MD'S NURSES ADMINISTERED. THEY MAY NOT HAVE USED THE FLOW RATE TUBING BECAUSE THE SYRINGE KEPT JUMPING OUT OF THE PUMP, WHICH THEY THEN TAPED DOWN. RPH STATED IF THAT IS THE CAUSE THE MEDICATION WOULD HAVE INFUSED INCORRECTLY AT THE FLOW RATE TUBING WOULD NOT BE ATTACHED TO CONTROL THE RATE. PT HAD INJECTION SITE REACTION OF REDNESS, BURNING ITCH, AND PAIN. RPH RECOMMENDED LONGER NEEDLE TO ASSIST. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314418 TUBING FREEDOM 60 SYR INF PUMP, INFUSION W / SYRINGE SET AND TUBING FRN REPRO-MED SYSTEMS, INC. / RMS MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR