BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT SUBCULTURE UNITS

    MDR report key: 495662 · Received September 10, 2003

    Report

    Report Number
    1039284-2003-00008
    Event Type
    Injury
    Date Received
    September 10, 2003
    Date of Event
    March 28, 2003
    Report Date
    September 10, 2003
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PRICKED FINGER WITH A SUB-CULTURE NEEDLE WHICH WAS CONTAMINATED WITH BLOOD FROM A PATIENT CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT SUBCULTURE UNITS * JTA BIOMERIEUX, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention