BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3% SURGISCREEN

    MDR report key: 3750149 · Received April 15, 2014

    Report

    Report Number
    2250051-2014-00031
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD MEDICAL HAS ASSESSED THIS EVENT AND DETERMINED IT TO BE A SERIOUS INJURY. OCD COMPLAINT DATABASE WAS REVIEWED. NO TRENDS IDENTIFIED. ISSUE ASSOCIATED WITH ACCIDENTAL MISHANDLING WHILE NOT WEARING GLOVES

    Description of Event or Problem · 1

    COMPLAINT REPORTER IS REPORTING AN EMPLOYEE FROM STEF (OCD STRASBOURG WAREHOUSE) RECEIVED SPLASHES FROM ONE BROKEN BOX OF ORTHO 3% SURGISCREEN RED CELL REAGENT ON HER LEFT HAND WHILE PREPARING AN ORDER. ON (B)(6) 2014, WHILE PREPARING AN ORDER, A STEF WAREHOUSE EMPLOYEE HAD LET A VIAL OF 3% SURGISCREEN RED CELL REAGENT FALL AND WHILE TRYING TO CATCH IT, THE VIAL HAD HIT THE PREPARATION TABLE AND BROKE. THE COMPLAINT REPORTER SAID THAT THE CONTENT OF THE VIAL HAD SPREAD OVER THE EMPLOYEE¿S LEFT HAND. THE COMPLAINANT SAID THAT THE EMPLOYEE WAS NOT WEARING PROTECTIVE GLOVES, THAT THERE WAS NO CUT DUE TO BROKEN GLASS PARTS AND THAT THE WAREHOUSE EMPLOYEE¿ HANDS WERE ALL CRACKED. THE COMPLAINANT SAID THAT THE EMPLOYEE HAD WASHED HER HAND WITH A SOAP SOLUTION AND THAT SHE WENT FOR A MEDICAL CONSULTATION FOR WHICH NO MEDICAL TREATMENT OR VIRAL PROPHYLAXIS WAS GIVEN.THE WAREHOUSE OPERATOR WENT FOR VIROLOGY TESTING AND SURVEILLANCE. COMPLAINT REPORTER STATED THAT THIS INCIDENT WAS RECORDED AS AN ACCIDENT AT WORK TO THEIR MEDICAL DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229038 3% SURGISCREEN REAGENT RED BLOOD CELLS KSZ ORTHO CLINICAL DIAGNOSTICS 3SS834

    Patients

    Seq Age Sex Outcome Treatment
    1 Other