BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT CULTURE BOTTLE

    MDR report key: 47523 · Received November 6, 1996

    Report

    Report Number
    1039284-1996-00005
    Event Type
    Injury
    Date Received
    November 6, 1996
    Date of Event
    October 31, 1996
    Report Date
    November 6, 1996
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    MDB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 OPERATOR'S LEFT INDEX FINGER, REQUIRING MEDICAL INTERVENTION (6 STITCHES). PT WAS PUT ON ORAL DYSOXICILLIN (OXICILLIN) DUE TO THE STAPH THAT WAS GROWING. DUE TO THE BOTTLE BREAK THERE IS NO BLOOD AVAILABLE TO DO A FINAL ID OF THE STAPH. THIS TREATMENT WAS BASED ON THE GRAM STAIN RESULTS. THE CUSTOMER IS EMPLOYED AS A FULL TIME MEDICAL TECHNOLOGIST IN THE LAB. THE INCIDENT HAPPENED AT 6:25 AM. THE PT WHOSE BOTTLE BROKE IS AN END STAGE CARCINOMA PT. THERE IS BLOOD DRAWN TO DO AN INFECTIOUS DISEASE WORK UP, HBSZAB, HIV, HTLV. NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT CULTURE BOTTLE MICROBIAL GROWTH MONITOR MDB ORGANON TEKNIKA CORP. NA 203634

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention