BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 16 TRI-LEVEL CONTROL

    MDR report key: 396435 · Received May 24, 2002

    Report

    Report Number
    2919069-2002-00005
    Event Type
    Other
    Date Received
    May 24, 2002
    Date of Event
    April 23, 2002
    Report Date
    May 22, 2002
    Manufacturer
    ABBOTT DIAGNOSTIC DIVISION/CELLDYN
    Product Code
    JPK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002 THE CUSTOMER WAS CUT WHILE OPENING THE NORMAL CONTROL VIAL LOT #16671. THE CUSTOMER WAS TAKING THE CAP OFF OF THE VIAL AND THE TUBE CRACKED IN HALF AND CUT THEIR THUMB. THE CUSTOMER WAS WEARING GLOVES. CUSTOMER TOOK OFF THE GLOVES AND RINSED THE CUT WITH 50% BLEACH SOLUTION FOLLOWED BY RINSING WITH WATER UNTIL THE BLEEDING STOPPED. NO FURTHER TREATMENT WAS SOUGHT. NO SERIOUS INJURY WAS REPORTED. THE ACCOUNT STATED THAT THE CONTROL VIAL HAD BEEN PREVIOUSLY OPENED. THE ACCOUNT DISPOSED OF THE CONTROL VIAL. THE ACCOUNT STATED THAT HEPATITIS AND HIV TESTS WERE PERFORMED ON THE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 16 TRI-LEVEL CONTROL CELL-DYN 16 TRI-LEVEL HEMATOLOGY CONTROL JPK ABBOTT DIAGNOSTIC DIVISION/CELLDYN NA 16671

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR