BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL BIO-BAG ENVIRONMENTAL CHAMBER TYPE CFJ

    MDR report key: 8797882 · Received July 17, 2019

    Report

    Report Number
    8797882
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 15, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    KZJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN MICROBIOLOGY, THE FINGER OF CAREGIVER WAS CUT ON GLASS VIAL. NO PATIENT BLOOD EXPOSURE, BUT CONCERNED ABOUT POSSIBLE CONTAMINATED GLOVES FROM PREVIOUS SAMPLES. THIS IS A SPECIMEN TUBE THAT THE SPECIMEN IS PUT INTO AND THEN ITS HEAT SEALED IN A BAG. THERE IS A VIAL END THAT GETS CRUSHED TO RELEASE SOME SORT OF PRESERVATIVE. THIS IS WHEN THE CAREGIVER FELT A POKE AND SAW THAT HE HAD BEEN CUT, AND FIGURED THAT THE VIAL WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592027 BD BBL BIO-BAG ENVIRONMENTAL CHAMBER TYPE CFJ DEVICE, GAS GENERATING KZJ BECTON DICKINSON AND COMPANY B02B036M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other