BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIFCO DESOXYCHOLATE AGAR

    MDR report key: 1911508 · Received November 24, 2010

    Report

    Report Number
    1119779-2010-00007
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    JSG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESOXYCHOLATE AGAR REQUIRES REHYDRATION FROM DEHYDRATED CULTURE MEDIA. DIRECTIONS TO PREPARE THE AGAR ARE TO BLEND THE REQUIRED AMOUNT OF POWDER AND WATER. MIXING THOROUGHLY. HEAT WITH FREQUENT AGITATION AND BOIL FOR 1 MINUTE TO COMPLETELY DISSOLVE THE POWDER. AVOID OVERHEATING AND DO NOT AUTOCLAVE. IT IS STANDARD LABORATORY PRACTICE FOR THE PREPARATION OF MEDIA TO ENSURE THAT FLASKS BEING HEATED ARE PROPERLY VENTED. IF HEATING CONTINUES AND THE PRESSURE IS NOT ADEQUATELY RELIEVED, THE PRESSURE AND TEMPERATURE CAN RISE TO A POINT THAT THE FLASK MAY BURST. IN THIS INSTANCE, THE CUSTOMER ADMITS TO IMPROPERLY VENTING THE CONTAINER WHILE HEATING. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AN EMPLOYEE WAS ATTEMPTING TO MAKE THIS MEDIA IN A TIGHTLY CAPPED ERLENMEYER FLASK. WHILE HEATING, THE EMPLOYEE WAS DISTRACTED AND FORGOT TO LOOSEN THE CAP. THE FLASK SHATTERED AND GLASS SHARDS CUT THE EMPLOYEE. THE WOUND REQUIRED STITCHES. THE CONTACT STATED THAT IN THE FUTURE, THE CAP WILL BE VENTED OR LOOSENED PRIOR TO APPLYING HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIFCO DESOXYCHOLATE AGAR JSG BD DIAGNOSTIC SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other