BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.8% RESOLVED PANEL A

    MDR report key: 1363062 · Received April 10, 2009

    Report

    Report Number
    2250051-2009-00118
    Event Type
    Malfunction
    Date Received
    April 10, 2009
    Date of Event
    March 16, 2009
    Report Date
    April 10, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN VIAL WAS DISCARDED BY USER. CUSTOMER STATES THAT INCIDENT REPORT WAS FILED WITH THE FACILITY'S RISK MANAGEMENT DEPARTMENT AS PER FACILITY PROTOCOL.

    Description of Event or Problem · 1

    USER OBTAINED A CUT ON ONE FINGER WHILE ATTEMPTING TO OPEN CELL 6 OF VRA126. THE BLOOD BANK TECH WAS HAVING DIFFICULTY OPENING THE VIALS. WHEN TECH ATTEMPTED TO OPEN CELL 6, THE NECK OF THE BOTTLE BROKE OFF. CUT WAS MINOR AND DID NOT REQUIRE STITCHES NOR MEDICAL ATTENTION. TECH DID NOT BECOME EXPOSED TO REAGENT RED CELLS DURING THE INCIDENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0.8% RESOLVED PANEL A REAGENT RED BLOOD CELLS KSZ ORTHO-CLINICAL DIAGNOSTICS, INC. VRA126

    Patients

    Seq Age Sex Outcome Treatment
    1