BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAC-T-ALERT

    MDR report key: 32045 · Received April 17, 1996

    Report

    Report Number
    MW1008882
    Event Type
    Malfunction
    Date Received
    April 17, 1996
    Date of Event
    March 28, 1996
    Report Date
    April 3, 1996
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RPTR WAS TRYING TO EXTRACT A BLOOD CULTURE BOTTLE FROM THE DEVICE WHEN THE BOTTLE BROKE CAUSING A LACERATION TO THE RIGHT THUMB. RPTR WENT TO THE ER FOR TREATMENT AND RECEIVED STITCHES AND A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAC-T-ALERT CONTINUOUS MONITORING BLOOD CULTURE JSC ORGANON TEKNIKA CORP. 203568

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR