BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMH RAPIDSCREEN

    MDR report key: 18628934 · Received February 2, 2024

    Report

    Report Number
    18628934
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 23, 2024
    Report Date
    January 23, 2024
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LIM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FETAL SCREEN KIT ARRIVED IN BLOOD BANK FROM MANUFACTURER. THE CAP FOR THE BOTTLE OF INDICATOR CELLS WAS NOT TIGHTLY SCREWED ON IN THE PACKAGING CAUSING THE CONTENTS TO LEAK. UNABLE TO USE FETAL SCREEN KIT DUE TO RISK OF CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288157 FMH RAPIDSCREEN TEST, SCREENING, FOR D POSITIVE FETAL RBC'S LIM IMMUCOR, INC. 0007893 51774

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown