BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JCF-Z ROTOR PACKAGE

    MDR report key: 1996777 · Received February 19, 2011

    Report

    Report Number
    2050012-2011-00498
    Event Type
    Malfunction
    Date Received
    February 19, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    1 A STOP SHIPMENT WAS ISSUED BY BCI FOR THIS ROTOR. ALL INVENTORY WAS PULLED BACK, REWORKED, AND HAS BEEN RE-RELEASED TO INVENTORY. THE ASSEMBLY WORK INSTRUCTION WILL BE UPDATED TO REFLECT TEST REQUIREMENTS FOR SHARPNESS. CURRENTLY, MANUFACTURING HAS IMPLEMENTED AN IN-PROCESS CHECK FOR SHARPNESS ON EVERY ROTOR PRODUCED. QC HAS ALSO IMPLEMENTED A DAILY CHECK FOR BURRS OR SHARP EDGES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THE USER HAS CUT FINGERS DUE TO THE SHARP EDGES OF THE JCF-Z ROTOR PACKAGE, USED IN THE J2-MI CENTRIFUGE. AFFECTED USER DID NOT SEEK MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JCF-Z ROTOR PACKAGE CENTRIFUGATION PRODUCT JQC BECKMAN COULTER INC. JCF-Z ROTOR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1