BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSITITRE MUELLER-HINTON BROTH W/TES

    MDR report key: 569508 · Received January 13, 2005

    Report

    Report Number
    2183729-2005-00001
    Event Type
    Other
    Date Received
    January 13, 2005
    Date of Event
    December 9, 2004
    Report Date
    January 11, 2005
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS, INC.
    Product Code
    JTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 2004, THE LAB TECH CALLED TO REPORT THEY WERE HAVING PROBLEM WITH BREAKING TUBES OF T3462 MUELLER-HINTON BROTH W/TES (MHB) IN USE WITH THE V3010 SENSITITRE AUTOINCULATOR. FIVE DAYS EARLIER, A TUBE INOCULATED WITH SALMONELLA (NEWPORT) BROKE AS USER WAS UNSCREWING THE DOSEHEAD FROM THE TUBE AFTER REMOVING IT FROM THE AUTOINOCULATOR. THE TUBE BROKE APPROX. 2 CM FROM THE TOP AND USER SUSTAINED A CUT TO THUMB ABOUT 16 MM LONG AND 2 MM DEEP. AS A PRECAUTIONARY MEASURE AND A REQUIREMENT OF FACILITY, USER WAS CHECKED OUT BY AN INFECTIOUS DISEASE SPECIALIST WHO PRESCRIBED CIPROFLOXACIN. USER DID NOT GET STITCHES. USER COULD HAVE GOT STITCHES BUT OPTED NOT TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSITITRE MUELLER-HINTON BROTH W/TES IN VITRO DIAGNOSTIC CULTURE MEDIA JTZ TREK DIAGNOSTIC SYSTEMS, INC. NA 143168SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other SENSITITRE AUTOINOCULATOR, CATALOG #V3010.