BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV CONNECT INV PLUS TOUCH SYST

    MDR report key: 8696576 · Received June 12, 2019

    Report

    Report Number
    MW5087336
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Report Date
    May 30, 2019
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE VELETRI MONTHLY CONSULT, PT'S DAUGHTER REPORTED AGAIN THAT THE GREEN CONNECTOR (RYM-5000 CONNECTOR-IVINVISION+) BROKE JUST LIKE ONE INCIDENT LAST MONTH. THE CONNECTOR IS NOT AVAILABLE FOR RETURN. INFUSION WAS NOT INTERRUPTED. NO SHORTNESS OF BREATH / ADVERSE EVENT REPORTED. SHE ALSO REPORTED THAT WHEN SHE WAS MIXING, SHE HAD DIFFICULTY TO USE THE SPIKE (BUDP1800SC SPIKE, MINI-DISPENSING). SHE SAID, "THE SPIKE WON'T PENETRATE THE RUBBER ON TOP OF THE VELETRI VIAL." SHE REQUESTED EXTRA SPIKES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487072 IV CONNECT INV PLUS TOUCH SYST SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-5000

    Patients

    Seq Age Sex Outcome Treatment
    1