BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSITITRE MUELLER-HINTON BROTH W/TES

    MDR report key: 1215489 · Received October 28, 2008

    Report

    Report Number
    2183729-2008-00001
    Event Type
    Other
    Date Received
    October 28, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 22, 2008
    Manufacturer
    TREK DIAGNOSTIC SYSTEMS
    Product Code
    JTZ
    PMA / PMN Number
    K802957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED COMPLAINTS FOR SIMILAR INCIDENTS. THERE WERE NO OTHER REPORTS TO TUBE BREAKAGE SINCE 2004. REVIEWED BATCH HISTORY RECORD. THERE WERE NO PROCESSING PROBLEMS OR UNUSUAL TUBE BREAKAGE DURING PROCESSING. REVIEWED USE OF THE TUBE LOT THAT WAS USED IN THIS BATCH OF BROTH.

    Description of Event or Problem · 1

    IN 2008, LAB MANAGER REPORTED: "WE HAD A LITTLE LAB ACCIDENT YESTERDAY WHERE THE PERSON WAS SCREWING ON A DOSE HEAD ON TO A MH BROTH TUBE AFTER INOCULATION AND THE NECK BROKE. THE GLASS DEEPLY CUT A FINGER AND REQUIRED STITCHES. A TUBE WAS ALSO BROKEN THE DAY BEFORE. THE LOT# IS 148641SA. WE ARE NOT IMPLANTING THE CRAFTSMANSHIP OF THE TUBE, BUT JUST WANTED TO LET EVERYONE KNOW AND SEE IF ANYONE ELSE HAS HAD PROBLEMS." TEN DAYS LATER, THE LAB MANAGER PROVIDED FURTHER DETAIL: "THE PERSON IS DOING WELL AND DOES NOT SEEM TO HAVE ANY ADVERSE PROBLEMS DUE TO THE INJURY (BESIDES THE CUT). AROUND 4:00 IN THE AFTERNOON IS WHEN THE INCIDENT OCCURRED AND THE PERSON WAS WORKING WITH AN E. COLI 0157:H7. THE PERSON HAD INOCULATED 10 UL FROM THE 0.5 EQUIVALENT TO THE 10 ML MH TUBE AND STARTED SCREWING THE DOSE HEAD ON, WHEN THE NECK BROKE. THE THUMB WAS SLICED OPEN AND WE TOOK THE PERSON TO THE OCCUPATIONAL HEALTH CLINIC HERE. THEY CLEANED THE WOUND, APPLIED 7 STITCHES, AND GAVE HIM BACTRIM AS A PRECAUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSITITRE MUELLER-HINTON BROTH W/TES JTZ TREK DIAGNOSTIC SYSTEMS NONE 148614SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention