BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 10791884 · Received November 5, 2020

    Report

    Report Number
    10791884
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 14, 2020
    Report Date
    October 22, 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

    MEDI-PLAST VIAL DECANTER FROM MICROTEK MEDICAL, INC. HAS ISSUES WITH THE VIAL DECANTER CAP NOT STAYING ON THE DECANTER SPIKE WHILE IN THE PACKAGE. THIS PROBLEM PREVENTS THE ASEPTIC DECANTING FROM GLASS VIALS. THE CAP FROM THIS PARTICULAR SUPPLY WAS NOT COVERING THE SPIKE (REF #2006S, LOT #200318).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259898 MICROTEK CONTAINER, I.V. KPE MICROTEK MEDICAL INC. 1 200318 00748426002511

    Patients

    Seq Age Sex Outcome Treatment
    1