BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEROBIC BLOOD CULTURE TEST

    MDR report key: 124547 · Received October 3, 1997

    Report

    Report Number
    1039284-1997-00004
    Event Type
    Injury
    Date Received
    October 3, 1997
    Date of Event
    September 12, 1997
    Report Date
    September 30, 1997
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    MDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL RECEIVED CUT ON THE LEFT MIDDLE FINGER FROM A BACT ALERT ANAEROBIC BLOOD CULTURE BOTTLE. THE INDIVIDUAL WAS UNLOADING BOTTLES FROM THE BACT ALERT INSTRUMENT WHEN A BOTTLE BROKE AT THE NECK. THE TECHNICIAN WAS NOT WEARING GLOVES AT THE TIME. THE TECHNICIAN WAS A 39 YEAR OLD MALE, APPROXIMATELY 175 POUNDS AND IN GOOD HEALTH. HE DID NOT GO TO THE HEALTH CENTER UNTIL LATER IN THE AFTERNOON BECAUSE HE WAS WAITING ON PAPER WORK TO BE COMPLETED. THE TECHNICIAN WAS GIVEN A TETANUS IMMUNIZATION. NO OTHER TREATMENT WAS GIVEN. THE TECHNICIAN RETURNED TO WORK AFTER RECEIVING TREATMENT. FREQUENCY OF OCCURENCE STATEMENT (21 CFR 803.24(C)(7)). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL OFFER PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND THE UNIVERSAL 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 OCCURENCE STATEMENT (21 CFR.803.24(C)(7)). THE PACKAGE INSERT AND INSTRUMENT OPERATOR'S MANUAL OFFER PRECAUTIONS CONCERNING POTENTIAL FOR GLASS BREAKAGE AND THE UNIVERSAL PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULTING FROM BREAKAGE OF THE GLASS BOTTLE ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELLING. CO BELIEVES THAT 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 ANEROBIC BLOOD CULTURE TEST MICROBIAL GROWTH MONITOR MDB ORGANON TEKNIKA CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention