BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI WASH BUFFER II

    MDR report key: 2444817 · Received February 9, 2012

    Report

    Report Number
    2122870-2012-00242
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 15, 2012
    Report Date
    January 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LDT
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GAP IN THE SEAM OF THE CUBITAINER CONTAINING THE UNICEL DXI WASH BUFFER II WAS RESPONSIBLE FOR THE OBSERVED LEAK. A DEFINITIVE ROOT CAUSE FOR THE GAP IN THE SEAM OF THE CUBITAINER HAS NOT YET BEEN DETERMINED.BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. (BEC) CUSTOMER SERVICE REPRESENTATIVE FROM THE BEC (B)(4) DISTRIBUTION FACILITY REPORTED A LEAK FROM A CONTAINER OF UNICEL DXI WASH BUFFER II. THERE WAS NO IMPACT TO PATIENT DATA OR PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORT OF INJURY TO THE CUSTOMER SERVICE REPRESENTATIVE ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER SERVICE REPRESENTATIVE REPORTED THAT THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI WASH BUFFER II GENERAL PURPOSE REAGENT LDT BECKMAN COULTER, INC. NA 331941F

    Patients

    Seq Age Sex Outcome Treatment
    1