BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 768245 · Received August 18, 2006

    Report

    Report Number
    1213809-2006-00074
    Event Type
    Malfunction
    Date Received
    August 18, 2006
    Date of Event
    July 20, 2006
    Report Date
    August 18, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE ADDITIONAL LOT NUMBERS WERE REPORTED, (6056345, 6074329 AND 6103375). A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED SEALED, UNUSED SAMPLES DID NOT CONFIRM ANY EVIDENCE OF IMPACT OR OTHER DAMAGE THAT MAY HAVE CONTRIBUTED TO THE CRACKED BARREL CONDITION REPORTED. INVESTIGATIONS ARE CURRENTLY ONGOING TO IDENTIFY THE POTENTIAL SOURCES CONTRIBUTING TO THIS CONDITION IN THE SYRINGE MANUFACTURE AND ASSEMBLY PROCESSES. A REVIEW OF OUR RECORDS INDICATE THAT NO PREVIOUS INCIDENTS HAVE BEEN REPORTED ON THE RETURNED LOT NUMBERS. ANALYSIS OF COMPLAINT DATA OVER THE PAST TWO YEARS REVEAL THAT THIS TYPE OF INCIDENT OCCURS AT A CHRONIC LOW LEVEL (0.030/MM) IN RELATION TO THE TOTAL VOLUME OF SYRINGES PRODUCED.

    Description of Event or Problem · 1

    WHEN TRYING TO FLICK THE BARREL TO REMOVE THE AIR BUBBLES, THE BARRELS SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SYRINGE 3ML DISPOSABLE LUER-LOK SYRINGE DXT BECTON DICKINSON NA 6090361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA