BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISION PLUS / RYM 5000

    MDR report key: 9706419 · Received February 12, 2020

    Report

    Report Number
    MW5092973
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 2, 2020
    Report Date
    January 16, 2020
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT REQUESTED DIFFERENT CONNECTOR FROM THE INVISION PLUS RYM 5000 FOR HIS IV VELETRI INFUSION. STATED 3 OF THEM WERE LEAKING AND BLOOD CAME OUT. MD REPLACED HIS GROSHONG AS PRECAUTION, BUT COULD NOT FIND ANY CRACKS. SHIPPING ALTERNATIVE CONNECTORS AND ASKED OUR RN TEAM TO F/U WITH PT FOR INSTRUCTION. CONNECTORS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFO AVAILABLE. REPORTED TO (B)(4) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166873 INVISION PLUS / RYM 5000 I.V, CONNECTORS LHI RYMED TECHNOLOGIES, INC. M01562
    166874 INVISION PLUS / RYM 5000 I.V, CONNECTORS LHI RYMED TECHNOLOGIES, INC. M01562
    166875 INVISION PLUS / RYM 5000 I.V, CONNECTORS LHI RYMED TECHNOLOGIES, INC. M01562

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR