BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0.8% RESOLVED PANEL A

    MDR report key: 1363073 · Received April 10, 2009

    Report

    Report Number
    2250051-2009-00120
    Event Type
    Injury
    Date Received
    April 10, 2009
    Date of Event
    March 19, 2009
    Report Date
    April 10, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN VIAL WAS DISCARDED BY THE CUSTOMER. A SCREENING TEST WAS PERFORMED ON THE SAMPLE WITH NEGATIVE RESULTS. CUSTOMER STATES THAT AN INCIDENT REPORT WILL BE FILED TO THE FACILITY 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 3 OF THE DEVICE. THE BLOOD BANK TECH WAS HAVING DIFFICULTY OPENING THE VIALS. WHEN THE TECH ATTEMPTED TO OPEN CELL 3 WITH A PAIR OF PLIERS, THE NECK OF THE BOTTLE BROKE OFF. USER RECEIVED A MINOR CUT. HE DID NOT REQUIRE STITCHES OR MEDICAL ATTENTION. THE TECH DID GET EXPOSED TO REAGENT RED CELLS DURING THE INCIDENT. MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY. 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 VRA126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other