BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR SLANTS W CHLORAMPHENICOL

    MDR report key: 11922065 · Received June 2, 2021

    Report

    Report Number
    1119779-2021-00942
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 12, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    UDI-DI
    30382902218259
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATERIAL 221825 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING 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. THE BATCH HISTORY RECORD REVIEW FOR BATCH 0302189 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 0302189 (10 TUBES) WERE AVAILABLE FOR INVESTIGATION. EACH TUBE (10/10) SHOWED NO SIGNS OF CONTAMINATION FROM VISUAL INSPECTION. FOR INVESTIGATION, A TWO UNINOCULATED RETENTION TUBES WERE INCUBATED FOR SEVEN DAYS. ONE WAS PLACED IN THE 33 TO 37 DEGREE C INCUBATOR AND ONE TUBE WAS PLACED IN THE 20 TO 25 DEGREE C INCUBATOR. NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION TUBES. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A TUBE AND ALONG THE SLANT THERE DOES APPEAR TO BE BACTERIAL LIKE COLONIES. THE SECOND PHOTO SHOWS A TUBE FROM BATCH 0302189; ALONG THE AGAR SLANT THERE APPEARS TO BE BACTERIAL COLONIES. THE COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, NO ACTIONS ARE PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ SABOURAUD DEXTROSE AGAR SLANTS WITH CHLORAMPHENICOL 30 PLATES HAD BACTERIAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: TUBES ARRIVED AT THE LAB WITH BACTERIA GROWTH. "GOOD MORNING, WE'VE HAD BACTERIAL CONTAMINATION IN THE DERMATOPHYTE CULTURE MEDIA."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD BBL¿ SABOURAUD DEXTROSE AGAR SLANTS WITH CHLORAMPHENICOL 30 PLATES HAD BACTERIAL CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: TUBES ARRIVED AT THE LAB WITH BACTERIA GROWTH. "GOOD MORNING, WE'VE HAD BACTERIAL CONTAMINATION IN THE DERMATOPHYTE CULTURE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820082 BD BBL¿ SABOURAUD DEXTROSE AGAR SLANTS W CHLORAMPHENICOL CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 221825 0302189 30382902218259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown