BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIFF AC-T PAK REAGENT 15L

    MDR report key: 2156005 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00649
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    January 29, 2010
    Report Date
    January 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PRODUCT LABELING ON THE MATERIAL SAFETY DATA SHEET (MSDS) (B)(4), PROVIDES THE FOLLOWING INSTRUCTION: "IF PRODUCT ENTERS EYES, WASH EYES GENTLY UNDER RUNNING WATER FOR 15 MINS OR LONGER, MAKING SURE EYELIDS ARE HELD OPEN. IF PAIN OR IRRITATION OCCUR, OBTAIN MEDICAL ATTENTION." THE MSDS ALSO CONTAINS THE FOLLOWING FOR EYE PROTECTION: "SAFETY GLASSES OR CHEMICAL GOGGLES SHOULD BE WORN TO PREVENT EYE CONTACT." PRODUCT LABELING ANALYSIS DETERMINED LABELING IS SUFFICIENT. ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED. USER ERROR CONTRIBUTED TO THE EVENT AS EYE PROTECTION WAS INSUFFICIENT TO PREVENT SPLASHING FROM ENTERING EYE AREA. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    AN OPERATOR REPORTED DILUENT WAS SPLASHED INTO HER EYES AS SHE WAS OPENING THE SEAL ON REAGENT #1 IN THE DIFF AC-T PAK REAGENT 15L. THE OPERATOR WAS WEARING SAFETY GLASSES, GLOVES AND LAB COAT. HOWEVER, HER SAFETY GLASSES WERE INSUFFICIENT TO PREVENT EXPOSURE. THE OPERATOR FLUSHED HER EYES WITH WATER FOR 15 MINS AND SOUGHT MEDICAL ATTENTION. THE OPERATOR STATED THAT SHE IS NOT INJURED. IT IS UNK IF INTERVENTION WAS REQUIRED WHEN THE OPERATOR SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIFF AC-T PAK REAGENT 15L GGK BECKMAN COULTER, INC. NA 114145K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COULTER ACT DIFF ANALYZER