BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT FN CULTURE BOTTLE

    MDR report key: 1418559 · Received March 30, 2009

    Report

    Report Number
    3002769706-2009-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 16, 2009
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THIS INCIDENT HAS BEEN INITIATED. THE CUSTOMER ALLEGES THAT THE ALUMINUM CRIMP SEAL WAS MISSING PRIOR TO USE. THE COMPLAINT STATES THAT THE USER REMOVED THE FLIP CAP AND INOCULATED THE BOTTLE THROUGH THE RUBBER STOPPER WITHOUT NOTICING THAT THE ALUMINUM SEAL WAS MISSING. THIS IS AN UNLIKELY SCENARIO SINCE THE FLIP TOP IS ATTACHED TO THE CRIMP SEAL WHICH COVERS THE RUBBER STOPPER. THE PICTURE PROVIDED BY THE USER SHOWS THE RUBBER STOPPER WITH "DENTS" OR GAUGES IN THE RUBBER STOPPER. THE INSTRUCTIONS FOR USE ADVISE TO VISUALLY INSPECT THE BOTTLES PRIOR TO USE AND NOT TO USE IF THERE IS EVIDENCE OF DAMAGE, LEAKAGE OR DETERIORATION.

    Description of Event or Problem · 1

    AN INCUBATOR MODULE RACK WAS CONTAMINATED BY SPILLED MEDIUM FROM A POSITIVE CULTURE BOTTLE WHICH CONTAINED SERRATIA SPP. IT WAS REPORTED THAT THE ALUMINUM CRIMP SEAL WAS MISSING FROM THE CULTURE BOTTLE AND THE RUBBER STOPPER WAS DISLODGED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT FN CULTURE BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1021290

    Patients

    Seq Age Sex Outcome Treatment
    1