BEUDAMED
    FDA Adverse Event Other Summary report: N

    BACTEC PLUS ANAEROBIC/F MEDIUM

    MDR report key: 1562890 · Received December 17, 2009

    Report

    Report Number
    1119779-2009-00012
    Event Type
    Other
    Date Received
    December 17, 2009
    Date of Event
    December 9, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BD CARIBE, LTD.
    Product Code
    JSL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLES FROM THE SAME LOT WERE VISUALLY INSPECTED FOR ANY BROKEN AND/OR CRACKED VIALS. ALL RESULTS WERE SATISFACTORY. REVIEW OF THE BATCH HISTORY RECORD DID NOT IDENTIFY ABNORMALITIES AS RELATED TO THIS ISSUE. ALTHOUGH BD IS UNABLE TO CONFIRM ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT, WE WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF ISSUE. BD WILL CONTINUE TO EDUCATE THE CUSTOMER CONCERNING PROPER HANDLING OF BACTEC BOTTLES AND ANY BREAKAGE THAT MAY OCCUR.

    Description of Event or Problem · 1

    A TECHNICIAN WAS REMOVING A BOTTLE FROM THE INSTRUMENT AND THE BOTTLE BROKE. THE TECHNICIAN WAS WEARING A LAB COAT AND GLOVES BUT DID RECEIVE A CUT. SHE RECEIVED A TETANUS SHOT. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC PLUS ANAEROBIC/F MEDIUM JSL BD CARIBE, LTD. 9257200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other