BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS DT CONTROL I

    MDR report key: 585388 · Received March 28, 2005

    Report

    Report Number
    1319808-2005-00066
    Event Type
    Other
    Date Received
    March 28, 2005
    Date of Event
    March 1, 2005
    Report Date
    March 1, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SELF INFECTED NEEDLE STICK WHEN USING A SYRINGE TO DRAW CONTROL FLUID THROUGH THE CAPPED BOTTLE. IMPROPER HANDLING OF THE DT1 CONTROL MATERIAL HAS THE POTENTIAL TO CAUSE THE TRANSMISSION OF DISEASE AS THERE IS NO COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS DT CONTROL I IN VITRO DIAGNOSTIC JJY ORTHO-CLINICAL DIAGNOSTICS NA T5652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other