BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAN AEROBIC BACT/ALERT BLOOD CULTURE TEST

    MDR report key: 183122 · Received August 17, 1998

    Report

    Report Number
    1039284-1998-00002
    Event Type
    Injury
    Date Received
    August 17, 1998
    Date of Event
    July 16, 1998
    Report Date
    August 14, 1998
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TECHNICIAN AT THIS SITE WAS UNLOADING NEGATIVE BOTTLES FROM THE BACT/ALERT INSTRUMENT AND ONE OF THE BOTTLES BROKE AT THE NECK. THE TECHNICIAN REC'D A SMALL CUT ON THE RIGHT FINGER WHEN THE BOTTLE BROKE. THE TECHNICIAN WENT TO THE EMPLOYEE HEALTH CENTER AND REC'D A TETANUS SHOT. THE SMALL CUT WAS CLEANED AND DRESSED. FREQUENCY OF OCCURRENCE STATEMENT (21 CFR 803.24 (C)(7)). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL OFFER PRECAUTIONS CONCERNING THE POTENTIAL FOR GLASS BREAKAGE AND THE UNIVERSAL PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. EXPECTED FREQUENCY OF CUTS RESULTING FROM BREAKAGE OF BOTTLES ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE FREQUENCY AT THE TIME OF THIS REPORT IS NO GREATER THAN USUAL FOR THE DEVICE. SEVERITY OF OCCURRENCE STATEMENT (21 CFR 803.24 (C)(7)). THE PACKAGE INSERT AND INSTRUMENT'S OPERATOR'S MANUAL OFFER PRECAUTIONS CONCERNING THE POTENTIAL FOR GLASS BREAKAGE AND THE UNIVERSAL PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULTING FROM THE BREAKAGE OF GLASS BOTTLES ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE DEGREE OF SEVERITY OF THIS INCIDENT IS NO GREATER THAN WOULD BE EXPECTED FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAN AEROBIC BACT/ALERT BLOOD CULTURE TEST MICROBIAL GROWTH MONITOR JTA ORGANON TEKNIKA CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention