BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE

    MDR report key: 550177 · Received July 12, 2004

    Report

    Report Number
    MW1032675
    Event Type
    Malfunction
    Date Received
    July 12, 2004
    Date of Event
    July 12, 2004
    Report Date
    July 12, 2004
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IN RESPONSE TO YOUR REQUEST FOR INFORMATION ON THE ABOVE REFERENCE REPORT, I HAVE ASSEMBLED THE FOLLOWING INFORMATION. THIS REPORT INDICATE THAT A PHARMACY TECHNICIAN NOTICED A GREEN GRASS-LIKE MATERIAL IN THE BARREL BELOW THE PLUNGER OF A BD 10ML SYRINGE. A SEARCH OF OUR FILES FAILED TO LOCATE THIS OR ANY SIMILAR REPORTS. BASED ON THE PACKAGE GRAPHICS NUMBER, DG515703 THAT THE REPORTER HAD ERRONEOUSLY INDICATED AS THE MODEL,CATALOG, AND OTHER ID, CO WAS ABLE TO ESTABLISH THAT THE DEVICE INVOLVED WAS A BD CATALOG #309604. NO LOT NUMBER WAS SUPPLIED. WITHOUT A LOT NUMBER OR THE ACTUAL DEVICE DISPLAYING THE REPORTED CONDITION OUR INVESTIGATION IS LIMITED TO A REVIEW OF CO'S COMPLAINT RECORDS AND AS I STATED EARLIER CO HAVE NO REPORTS MATCHING THIS DESCRIPTION. IN GENERAL, CUSTOMER COMPLAINTS INVOLVING FOREIGN MATTER ON BD SYRINGES OCCUR VERY INFREQUENTLY. OVER THE PAST TWO YEARS THE COMPLAINT RATE FOR THIS CONDITION HAS BEEN WELL BELOW 1 IN 10,000,000.

    Description of Event or Problem · 1

    PHARMACY TECHNICIAN REMOVED A 10ML SYRINGE FROM THE WRAPPER TO ADMIX IV MEDICATIONS. A GREEN GRASS-LIKE MATERIAL WAS NOTICED IN THE BARREL OF THE SYRINGE IN THE AREA BELOW THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD 10ML SYRINGE SYRINGE WITH LUER-LOK TIP FMF BECTON, DICKINSON AND CO. DG515703 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other