BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FACS SAMPLE PROCESSOR SP-1

    MDR report key: 543302 · Received September 10, 2004

    Report

    Report Number
    2916837-2004-00001
    Event Type
    Injury
    Date Received
    September 10, 2004
    Date of Event
    August 11, 2004
    Report Date
    September 9, 2004
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED DURING A ROUTINE SERVICE CALL. A FIELD SERVICE ENGINEER(FSE) WAS PERFORMING A SP-1 PROBE CHANGE. THE FSE DISPOSING OF THE CONTAMINATED PROBE. THIS PROBE WAS SUPPOSED TO BE PLACED IN A BIOHAZARD CONTAINER, BUT THE FSE TRIED TO PLACE THE CONTAMINATED PROBE INTO THE PACKAGING OF THE NEW PROBE BEFORE DISPOSING OF IT. UPON DOING THIS THE FSE SCRATCHED THEIR FINGER SUPERFICIALLY WITH THE OLD CONTAMINATED PROBE. THE FSE STATED,"WHY WAS I SO STUPID TO TAKE THE EFFORT TO PUT THE TUBING OVER THE PROBE IF IT WAS FOR DISPOSAL. A NEEDLE IS A NEEDLE, I SHOULD HAVE THROWN IT AWAY." THIS EVENT HAPPENED IN A HIV-SPECIALIZED INSTITUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FACS SAMPLE PROCESSOR SP-1 APPARATUS AUTOMATED BLOOD CELL DILUTING GKH BD BIOSCIENCES SP-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention