BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 10800444 · Received November 6, 2020

    Report

    Report Number
    10800444
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MICROTEK MEDICAL INC.
    Product Code
    KPE
    UDI-DI
    00748426002511
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CAP COVERING THE SPIKE OF THE MICROTEK MEDICAL INC. MEDI-PLAST VIAL DECANTERS COMES OFF IN THE PACKAGING. UNABLE TO USE THE VIAL DECANTER ASEPTICALLY BECAUSE THE SPIKE IS COMPROMISED WITH THE COVER OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264422 MICROTEK CONTAINER, I.V. KPE MICROTEK MEDICAL INC. 1 200402 00748426002511

    Patients

    Seq Age Sex Outcome Treatment
    1