BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN CX AMMONIA/ALCOHOL CONTROL

    MDR report key: 2438681 · Received February 3, 2012

    Report

    Report Number
    2050012-2012-00387
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DKC
    PMA / PMN Number
    K934467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - CONCLUSION: THE LACERATION WAS CAUSED BY THE METAL SEAL ON THE BOTTLE.

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2012 REPORTING THAT ONE OF HER LABORATORY TECHNICIANS CUT HIS FINGER WHILE ATTEMPTING TO OPEN A BOTTLE OF BECKMAN CX AMMONIA/ALCOHOL CONTROL AS HE ATTEMPTED TO REMOVE THE METAL SEAL FROM THE BOTTLE. CUSTOMER REPORTED THAT THE TECHNICIAN WAS NOT WEARING GLOVES AT THE TIME OF THE INCIDENT. THE TECHNICIAN DID SEEK MEDICAL ATTENTION AND WAS TREATED FOR A SMALL LACERATION ON HIS RIGHT THUMB BUT DID NOT REQUIRE STITCHES. THE TECHNICIAN ALSO RECEIVED A TETANUS SHOT AS PROPHYLAXIS FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN CX AMMONIA/ALCOHOL CONTROL ALCOHOL CONTROL METERIALS DKC BECKMAN COULTER INC. CX AMMONIA/ALCOHOL CONTROL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1