BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK MEDICAL INC.

    MDR report key: 10983457 · Received December 10, 2020

    Report

    Report Number
    1043582-2020-00011
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 10, 2020
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KPE
    UDI-DI
    50748426002516
    PMA / PMN Number
    K811269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VIAL DECANTER SPIKE CAP CAME OFF IN THE PACKAGING WHICH COMPROMISED THE USERS' ABILITY TO ASEPTICALLY DECANT IV FLUIDS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453942 MICROTEK MEDICAL INC. VIAL DECANTER KPE MICROTEK MEDICAL INC. 2006S 200402 50748426002516

    Patients

    Seq Age Sex Outcome Treatment
    1