BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV CONNECT INV PLUS TOUCH SYST

    MDR report key: 8662470 · Received May 31, 2019

    Report

    Report Number
    MW5087083
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 24, 2019
    Report Date
    May 24, 2019
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT'S CONNECTOR WAS LEAKING DURING THE NIGHT. SHE MISSED ABOUT 6 HOURS OF REMODULIN. SHE WAS AWARE OF THE 4 HOURS WINDOW. SHE HAD ATTEMPTED TO RECONNECT EVERYTHING AND IT WAS LEAKING BETWEEN THE GREEN AND WHITE PART STILL. SHE STARTED A NEW ONE AND WAS ABLE TO GET EVERYTHING BACK WORKING AT 5:30 THIS MORNING. SHE DID RESTART AT HER CURRENT DOSE AND IS EXPERIENCING HEADACHE AND STOMACHACHE. SHE DID REACH OUT AND LEAVE A MESSAGE AT HER MD OFFICE ALREADY. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453939 IV CONNECT INV PLUS TOUCH SYST SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC M01513

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR