BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAMPLE CUPS, 0.5 ML

    MDR report key: 2414352 · Received January 12, 2012

    Report

    Report Number
    2050012-2012-00120
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    NNI
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC INITIAL INVESTIGATION AFTER RECEIVING THE COMPLAINT INDICATED THAT THE MALFUNCTION WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY UPON RECURRENCE. UPON FURTHER INVESTIGATION, BEC HAS DETERMINED THAT THE MALFUNCTION MIGHT CAUSE A DELAY IN REPORTING PATIENT RESULTS. THEREFORE, BEC IS FILING THIS MEDWATCH REPORT AT THIS TIME. BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WERE SOME 0.5 ML SAMPLE CUPS WITH HOLES IN THEM FROM A BAG OF LOT 1042839. CUSTOMER REPORTED THAT THE SAMPLE CUPS HAVE NOT BEEN USED. THERE WAS NO REPORT OF ANY ERRONEOUS RESULTS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT BEC SENT A REPLACEMENT OF 0.5 ML SAMPLE CUPS TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAMPLE CUPS, 0.5 ML CONTAINER, SPECIMEN, NON-STERILE NNI BECKMAN COULTER, INC. 1042839

    Patients

    Seq Age Sex Outcome Treatment
    1