BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACTEC LYTIC/10 ANAEROBIC/F MEDIUM

    MDR report key: 1426307 · Received July 30, 2009

    Report

    Report Number
    1119779-2009-00007
    Event Type
    Other
    Date Received
    July 30, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 29, 2009
    Manufacturer
    BD CARIBE, LTD.
    Product Code
    JSL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONVERSATION WITH THE TECHNICIAN REVEALED THAT SHE WAS PULLING A POSITIVE BLOOD CULTURE FROM THE TOP INSTRUMENT IN ONE OF THE TOP RACKS. SHE IS SHORT IN STATURE, SO WHEN SHE PULLED ON THE BOTTLE IT SPLASHED DOWN ONTO HER FACE, EYES AND LAB COAT. A GRAM STAIN WAS DONE ON THE BOTTLE WITH NO ORGANISMS SEEN AND NO GROWTH WAS OBSERVED FROM THE SUBCULTURE. THE PT TESTED NEGATIVE FOR (B)(6) IN (B)(6). TECHNICIAN INDICATED EMPLOYEE HEALTH DREW BLOOD AND RAN TESTS. NO FURTHER TEST RESULTS OR TREATMENT DETAILS HAVE BEEN PROVIDED. NO ADDITIONAL INVESTIGATION REGARDING THE CULTURE BOTTLE COULD BE CONDUCTED DUE TO THE INABILITY TO RETRIEVE A LOT NUMBER OF THE BROKEN BACTEC BLOOD CULTURE VIAL. NO RETURNS ARE RECEIVED DUE TO THE NATURE OF THE COMPLAINT. BD WILL CONTINUE TO EDUCATE THE CUSTOMER CONCERNING PROPER HANDLING OF BACTEC BOTTLES AND ANY BREAKAGE THAT MAY OCCUR. BD WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    A BLOOD CULTURE VIAL WAS BROKEN DURING REMOVAL FROM THE HOSPITAL'S BACTEC INSTRUMENT. THE TECHNICIAN WAS SPLASHED WITH BLOOD AND CULTURE MEDIA IN THE FACE. SHE WAS WEARING GLOVES AND A LAB COAT BUT WAS NOT WEARING SAFETY GLASSES. HER FACE AND EYES WERE RUN THROUGH RUNNING WATER FOR A MINUTE AND SHE WAS SENT TO EMPLOYEE HEALTH FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC LYTIC/10 ANAEROBIC/F MEDIUM JSL BD CARIBE, LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other