BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, I.V. FLUID TRANSFER

    MDR report key: 13994346 · Received April 4, 2022

    Report

    Report Number
    13994346
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    December 8, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDICAL SPECIALTY INNOVATIONS, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A FOREIGN PARTICLE FOUND ON THE SIDE OF THE LUMEN OF THE SPIKE OF THE MEDICAL SPECIALTY INNOVATIONS, INC. BAGFLOW SINGLE-USE DECANTER (PART #650, LOT# 0690). THIS IS THE SECOND TIME THAT A FOREIGN PARTICLE IS FOUND INSIDE THE BAGFLOW DECANTER. HEALTH CARE PROVIDER NOTIFIED STAFF TO LOOK FOR THIS, BUT THIS IS THE SECOND TIME IT HAS HAPPENED IN A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62232 SET, I.V. FLUID TRANSFER LHI MEDICAL SPECIALTY INNOVATIONS, INC. 650 0690

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male