BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAEROBIC BLOOD CULTURE BOTTLE

    MDR report key: 13933 · Received April 12, 1994

    Report

    Report Number
    13933
    Event Type
    Malfunction
    Date Received
    April 12, 1994
    Date of Event
    April 4, 1994
    Report Date
    April 11, 1994
    Manufacturer
    DIFCO LABORATORIES
    Product Code
    JSL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SYRINGE WITH 20 CC OF THE PT'S BLOOD WAS ATTACHED TO AN ANAEROBIC BLOOD CULTURE BOTTLE. THE SYRINGE IMMEDIATELY EMPTIED INTO THE BOTTLE. THE BOTTLE THEN FORCEFULLY BROKE INTO SEVERAL PIECES. BLOOD AND GLASS SPRAYED ONTO THE WALL AND THE PHLEBOTOMY TABLE. THERE WAS NO INJURY OR FLUID EXPOSURE REPORTED TO THE PT OR THE PHLEBOTOMIST. THE MFR WAS NOTIFIED OF THE EVENT, AND ALL REMAINING BLOOD CULTURE BOTTLES FROM THAT LOT WERE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANAEROBIC BLOOD CULTURE BOTTLE ANAEROBIC BLOOD CULTURE BOTTLE JSL DIFCO LABORATORIES UNKNOWN 17488

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other