BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.10

    MDR report key: 16882201 · Received May 5, 2023

    Report

    Report Number
    1119779-2023-00531
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 13, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217870
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE BRAND NAME: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 221787 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. CUSTOMER DID NOT PROVIDE A BATCH NUMBER, PHOTOS OR RETURNS FOR THIS COMPLAINT INVESTIGATION. TRENDING WAS DONE ON THE APPROPRIATE DATABASES FOR THIO VITAMIN K HEMIN 8ML (MATERIAL 221787), AND NO QUALITY NOTIFICATION TRENDS HAVE BEEN IDENTIFIED FOR THIS MATERIAL FOR CONTAMINATION TUBE IN THE LAST 12 MONTHS. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 221787 AND THERE ARE NO TRENDS FOR CONTAMINATION IN THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND COMPLAINTS FOR THIS ISSUE. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON MATERIAL TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN APPEARANCE IS CLOUDY AND WHEN GRAM STAIN WAS PERFORMED GRAM NEGATIVE BACILLI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE THIO´S ARE SLIGHTLY MORE "CLOUDY" THAN USUAL AND WHEN THEY PERFORM A GRAM STAIN ON THEM, THEY TURN OUT TO BE FULL OF GRAM NEGATIVE BACILLI. THEY ARE GOING TO DO ANOTHER STERILITY CHECK THEIRSELF, BUT THEY HEAR FROM COLLEAGUES IN OTHER LABORATORIES, WITH THE SAME PROBLEM, THAT THEY REMAIN NEGATIVE. NEVERTHELESS, THIS HAS A SERIOUS IMPACT ON THEIR WORKING METHOD. THEY ALWAYS MAKE A GRAM STAINING OF GROWN THIO´S.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN APPEARANCE IS CLOUDY AND WHEN GRAM STAIN WAS PERFORMED GRAM NEGATIVE BACILLI. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE THIO´S ARE SLIGHTLY MORE "CLOUDY" THAN USUAL AND WHEN THEY PERFORM A GRAM STAIN ON THEM, THEY TURN OUT TO BE FULL OF GRAM NEGATIVE BACILLI. THEY ARE GOING TO DO ANOTHER STERILITY CHECK THEIRSELF, BUT THEY HEAR FROM COLLEAGUES IN OTHER LABORATORIES, WITH THE SAME PROBLEM, THAT THEY REMAIN NEGATIVE. NEVERTHELESS, THIS HAS A SERIOUS IMPACT ON THEIR WORKING METHOD. THEY ALWAYS MAKE A GRAM STAINING OF GROWN THIO´S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212305 SEE H.10 CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221787 2251076 30382902217870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown