BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROBIC BLOOD CULTURE TEST BOTTLE

    MDR report key: 107509 · Received July 22, 1997

    Report

    Report Number
    1039284-1993-00003
    Event Type
    Injury
    Date Received
    July 22, 1997
    Date of Event
    July 15, 1997
    Report Date
    July 18, 1997
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    JTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL RECEIVED CUTS TO SEVERAL FINGERS FROM A BACT ALERT BLOOD CULTURE BOTTLE. THIS TECHNICIAN CUT LEFT INDEX FINGER, LEFT THUMB AND TWO RIGHT INDEX FINGERS FROM A BOTTLE WHICH BROKE DURING REMOVAL FROM BACT ALERT SYSTEM. THE TECHNICIAN TRIED TO FORCE BOTTLE OUT AND DID NOT FOLLOW PROTOCOL. THE INDIVIDUAL HAD TO HAVE THREE STITCHES IN THE CUT ON THE LEFT THUMB. THE INDIVIDUAL WAS NOT WEARING GLOVES AND WILL NOT GIVE ANY PERSONAL INFO ABOUT HERSELF SUCH AS AGE OR WEIGHT. FREQUENCY OF OCCURRENCE 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. THE 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 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 LABELING. THE 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 AEROBIC BLOOD CULTURE TEST BOTTLE MICROBIAL GROWTH MONITOR JTA ORGANON TEKNIKA CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention