BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE

    MDR report key: 2421940 · Received January 19, 2012

    Report

    Report Number
    1061932-2012-00181
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KRX
    PMA / PMN Number
    K912357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: EVALUATION WAS DONE BY THE CUSTOMER. CUSTOMER STATED THAT THE SEASON FOR THE LEAK WAS THAT THE CAP WAS NOT SCREWED ON TIGHTLY ON ONE OF THE TWO VIALS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 REPORTING THAT UPON OPENING A SHIPMENT OF THE ACT 5 CALIBRATOR, ONE OF THE VIAL WAS FOUND TO HAVE LEAKED (APPROXIMATELY 2 ML) INSIDE THE PRODUCT BOX. CUSTOMER STATED THAT THE PACKAGE WAS OPENED TO FIND IF THE VIAL WAS BROKEN BUT FOUND THAT THE VIAL WAS INTACT. CUSTOMER MENTIONED THAT THE REASON FOR THE LEAK WAS THAT THE CAP WAS NOT SCREWED ON TIGHTLY ON ONE OF THE 2 VIALS. THE PACKAGE WAS DISPOSED OF IN CUSTOMER'S BIOHAZARD CONTAINER AND HOTLINE HAD ARRANGED FOR A REPLACEMENT. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF THE EVENT AND NO ONE WAS EXPOSED TO THE LEAK. CUSTOMER ALSO REPORTED THAT NO INJURY HAD RESULTED FROM THE EVENT. ROOT CAUSE FOR THE LEAK IS POTENTIALLY ATTRIBUTED TO THE CAP NOT BEING SCREWED ON TIGHTLY ONTO THE VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE CALIBRATOR FOR CELL INDICES KRX BECKMAN COULTER, INC. ACT 5 CALIBRATOR CX436

    Patients

    Seq Age Sex Outcome Treatment
    1