BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCOLOR WRIGHT STAIN

    MDR report key: 2276834 · Received September 23, 2011

    Report

    Report Number
    1061932-2011-01501
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    March 10, 2009
    Report Date
    March 12, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKL
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. FOUND DAMAGED CONTAINER/LEAK FROM ORIGINAL EQUIPMENT MFR (OEM) VENDOR DURING PICK AND PACK PROCESS. BASED ON AVAILABLE INFO, THE ROOT CAUSE CAN BE ATTRIBUTED TO PRODUCT PACKING WAS DAMAGED ON ARRIVAL, CAUSING THE REAGENT TO LEAK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDR THAT HAVE BEEN REPORTED: MDR 1061932-2011-01500.

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. (BCI) EMPLOYEE REPORTED THREE CASES OF TRUCOLOR WRIGHT STAIN SOLUTION LEAKING FROM THEIR PACKAGES. THE EVENTS OCCURRED IN TWO SEPARATE DATES WHILE THE EMPLOYEE WAS PACKING THE CASES AND INVOLVED TWO DIFFERENT LOT NUMBERS. THE POTENTIAL FOR CHEMICAL EXPOSURE WITH THE REPORTED INCIDENT WAS PRESENT. AT ONE OF THE EVENTS THE BCI EMPLOYEE REPORTED WHEN LIFTING THE CASE IN THE SHIPPING AREA ITS CONTENT LEAKED FROM THE BOX AND FELL ON THE CLOTHING. THE EMPLOYEE USED THE EMERGENCY SHOWER AND WAS SENT HOME TO CHANGE CLOTHING. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTION EQUIPMENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN SKIN LESIONS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED AND THE LAB'S EXPOSURE CONTROL OR RISK MGMT PLANS ARE IN PLACE. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT AS A RESULT OF THIS EVENT. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 2 EVENTS REPORTED BY THIS CUSTOMER AND PRODUCT QUANTITY OF (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUCOLOR WRIGHT STAIN GKL BECKMAN COULTER, INC. NA 9030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK