BEUDAMED
    FDA Adverse Event Other Summary report: N

    10ML BD LUER LOK

    MDR report key: 1023721 · Received March 28, 2008

    Report

    Report Number
    1213809-2008-00004
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 28, 2008
    Manufacturer
    BECTON DICKINSON DIVISION
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT RESULTED FROM A DEVICE MALFUNCTION OR USER'S TECHNIQUE. IN ADDITION, THE LOT NUMBER IS UNK, THEREFORE, WE ARE UNABLE TO RUN A DEVICE HISTORY REVIEW. AS OF THIS DATE, REPORTS OF LEAKAGE PAST THE SYRINGE STOPPER, (B) (4). AS IN ALL INSTANCES, REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR FOR ANY CHANGES IN MONTHLY TRENDS.

    Description of Event or Problem · 1

    AS REPORTED, THERE WAS ONE INCIDENT WHERE THE SEAM OF THE SYRINGE SPLIT NEAR THE TIP, CAUSING BLOOD TO LEAK. THE PHYSICIAN APPARENTLY STOPPED USING THE SYRINGE AND PLACED IT ON A BACK TABLE. A TECHNICIAN PICKED IT UP AND INADVERTENTLY PRESSED THE PLUNGER, CAUSING BLOOD TO BE SPRAYED INTO THE PHYSICIAN'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10ML BD LUER LOK 10ML BD CONTROL SYRINGE, BULK, NON-STERILE FMF BECTON DICKINSON DIVISION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other