BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4C PLUS COULTER CELL CONTROL

    MDR report key: 2271115 · Received September 30, 2011

    Report

    Report Number
    1061932-2011-01579
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MSDS WAS NOT REVIEWED, HOWEVER IT IS READILY AVAILABLE. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. 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 LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE CONTROL TUBE WAS NOT REPLACED SINCE THE DAMAGED VIAL HAD BEEN PREVIOUSLY USED AND WAS ALREADY HALF AT THE TIME OF THE EVENT. THE ROOT CAUSE OF THE LEAK IS UNKNOWN. BEC INTERNAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT THE 4C PLUS COULTER CELL CONTROL TUBE WAS LEAKING. PER THE CUSTOMER, THE CONTROL HAD BEEN USED TWICE IN PREVIOUS OCCASIONS AND WAS HALF FULL WHEN THE INCIDENT OCCURRED. THE CONTROL WAS STORED IN A CUP IN THE REFRIGERATOR. THE CUSTOMER PICKED UP THE GLASS TUBE TO WIPE THE LEAK, THE GLASS VIAL BROKE AND THE CONTENTS SPILLED. THE CUSTOMER DID NOT CUT HERSELF WITH THE BROKEN GLASS NOR WAS EXPOSED TO THE CONTENTS OF THE CONTROL TUBE. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT AND GLOVES AT THE TIME OF THE EVENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4C PLUS COULTER CELL CONTROL MIXTURE, HEMATOLOGY QUALITY CONTROL JPK BECKMAN COULTER, INC. NA 1109276K

    Patients

    Seq Age Sex Outcome Treatment
    1