BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT CULTURE BOTTLE

    MDR report key: 42486 · Received October 9, 1996

    Report

    Report Number
    1039284-1996-00004
    Event Type
    Injury
    Date Received
    October 9, 1996
    Date of Event
    September 27, 1996
    Report Date
    October 8, 1996
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    MDB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REMOVE A BLOOD CULTURE BOTTLE FROM INSTRUMENT, THE BOTTLE BROKE. THIS RESULTED IN A CUT TO THE TECHNOLOGIST'S RIGHT INDEX FINGER, REQUIRING MEDICAL INTERVNTION. (TETANUS SHOT AND 2 STITCHES). FREQUENCY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. EXPECTED FREQUENCY OF CUTS RESULTING FROM BREAKAGE OF THE GLASS BOTTLE ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE FREQUENCY AT THE TIME OF THIS REPORT IS NOT GREATER THAN IS USUAL FOR THE DEVICE. SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24(C)(7). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL CONTAIN PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULTING FROM GLASS BOTTLE BREAKAGE IS NOT SPECIFCALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THE DEGREE OF SEVERITY OF THIS INCIDENT IS NOT GREATER THAN WOULD BE EXPECTED FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT CULTURE BOTTLE MICROBIAL GROWTH MONITOR MDB ORGANON TEKNIKA CORP. NA 104795

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention