BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROBIC BLOOD CULTURE TEST

    MDR report key: 150230 · Received February 18, 1998

    Report

    Report Number
    1039284-1998-00001
    Event Type
    Injury
    Date Received
    February 18, 1998
    Date of Event
    January 23, 1998
    Report Date
    February 18, 1998
    Manufacturer
    ORGANON TEKNIKA CORP
    Product Code
    MDB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL RECEIVED A CUT ON THE RIGHT INDEX FINGER FROM A POSITIVE BACT/ALERT AEROBIC BLOOD CULTURE BOTTLE. THE INDIVIDUAL WAS UNLOADING BOTTLE FROM THE BACT/ALERT INSTRUMENT WHEN A BOTTLE BROKE AT THE NECK. THE TECHNICIAN WAS WEARING GLOVES AND WASHED HER HANDS AND IMMEDIATELY WENT TO THE INFECTION CONTROL NURSE. THE TECHNICIAN RECEIVED A HEPATITIS VACCINE, HAD BLOOD DRAWN FOR TESTING, AND HAD HER WOUND CLEANED AND DRESSED. SHE WAS ALSO GIVEN ANTIBIOTICS FOR THE WOUND. 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 INFECTIONS BODY FLUIDS. EXPECTED FREQUENCY OF CUTS RESULTING FROM BREAKAGE OF GLASS 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 POTENTIAL FOR GLASS BREAKAGE AND THE UNIVERSAL PRECAUTIONS FOR HANDLING POTENTIALLY INFECTIOUS BODY FLUIDS. THE DEGREE OF SEVERITY OF CUTS RESULITING FROM THE BREAKAGE OF THE GLASS BOTTLES ARE NOT SPECIFICALLY ADDRESSED IN THE PRODUCT LABELING. CO BELIEVES THAT THE DEGREE OF SEVERITY OF THIS INCIDENT IS NO GREATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROBIC BLOOD CULTURE TEST MICROBIAL GROWTH MONITOR MDB ORGANON TEKNIKA CORP NA 203959

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention