BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS WASH BUFFER II SOLUTION

    MDR report key: 2302202 · Received October 20, 2011

    Report

    Report Number
    2122870-2011-04646
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Date of Event
    September 29, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF A CUSTOMER SUPPLIED PHOTO SUPPORTS THE CLAIM OF ONE CUBETAINER LEAKING APPROXIMATELY 1 LITER OF WASH BUFFER II SOLUTION WITH COLLATERAL DAMAGE TO AN ADDITIONAL 4 BOXES OF WASH BUFFER II SOLUTION. THE PHOTOS DISPLAY THE STACKING OF BOXES ON THEIR SIDE AND UPSIDE DOWN. UPRIGHT STORAGE OF WASH BUFFER II SOLUTION IS NECESSARY. THE NECK ATTACHMENT IS A MECHANICAL SEAL, AND HENCE WASH BUFFER II LIQUID IN CONTACT WITH THE SEAM CAN ALLOW WEEPING OF LIQUID AND DAMAGE SIMILAR TO THAT SEEN IN ATTACHED PHOTO. IT IS UNKNOWN WHETHER THE CUSTOMER STORED THE WASH BUFFER II SOLUTION IN THE MANNER DISPLAYED IN THE PHOTO. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, THEY RECEIVED FIVE DAMAGED DXI WASH BUFFER II BOXES THAT CAUSED THEIR CONTENT, OF WASH BUFFER II CUBETAINERS, TO LEAK. IT IS UNKNOWN AS TO WHETHER PERSONNEL HANDLING THE BOXES OR CUBETAINERS WERE WEARING PERSONAL PROTECTIVE EQUIPMENT; HOWEVER, THERE WAS NO REPORT OF ANY PERSONNEL SEEKING MEDICAL ATTENTION ASSOCIATED WITH THIS EVENT. THE ISSUE WAS DETECTED IN A DEALER'S WAREHOUSE. THE AMOUNT OF LEAKAGE FOR THIS EVENT COULD NOT BE DETERMINED. ALTHOUGH THE FLUID VOLUME OF AN ACCESS WASH BUFFER II CUBETAINER IS THEORETICALLY SIGNIFICANT ENOUGH TO CAUSE A SLIPPING HAZARD IF IT IS SPILLED, THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE FACILITY POSSESSES A HAZARDOUS EXPOSURE PLAN AND THE MATERIAL SAFETY DATA SHEET WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS WASH BUFFER II SOLUTION REAGENT, GENERAL PURPOSE LDT BECKMAN COULTER, INC. NA 331874F

    Patients

    Seq Age Sex Outcome Treatment
    1