BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-PLAST C-FLO BAG DECANTER

    MDR report key: 16983571 · Received May 22, 2023

    Report

    Report Number
    MW5117754
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 18, 2023
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE USE THE MICROTEK C-FLOW BAG DECANTER WITH A BAG OF HEPARIN AND IT WAS NOTICED THAT IT HAD A "BLUE COLORED PARTICULATE" IN MULTIPLE BAGS WITH A BLUE STOPPER AND A "WHITE/TRANSLUCENT PARTICULATE" IN BAGS THAT HAS A TRANSLUCENT STOPPER. REFERENCE REPORT: MW5117755.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183314 MEDI-PLAST C-FLO BAG DECANTER CONTAINER, I.V. KPE MICROTEK MEDICAL INC. 1 221126

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention HEPARIN SODIUM INJECTION