BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN

    MDR report key: 11732805 · Received April 27, 2021

    Report

    Report Number
    1119779-2021-00724
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 21, 2021
    Report Date
    September 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217429
    PMA / PMN Number
    K803023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MATERIAL 221742 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 0302188 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILING, AUTOCLAVING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. IF FOREIGN MATTER HAD BEEN NOTED DURING QC TESTING, THE PRODUCT WOULD HAVE BEEN PLACED ON QUALITY NOTIFICATION AND FURTHER ANALYSIS INCLUDING 100% INSPECTION OF THE BATCH WOULD HAVE BEEN CONDUCTED. 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 0302188 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO MEDIA, DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO RETENTION SAMPLES WERE TESTED. ONE TUBE WAS PLACED IN THE 33-TO-37-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED IN THE 20-TO-25-DEGREE CELSIUS INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 2/2 INCUBATED RETENTION TUBES AT SEVEN DAYS INCUBATION. THE MEDIA IN THE TUBES WAS ALSO PLATED ON TO TSA SHEEP BLOOD AGAR PLATES. NO MICROBIAL GROWTH WAS OBSERVED AFTER THE INCUBATED MEDIA WAS PLATED. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BOTH PHOTOS ARE SIMILAR AND SHOW A PARTIAL TUBE HELD UP, EMPHASIS FOCUSING ON THE MEDIA. THE MEDIA IN THE PHOTOS DOES APPEAR TO BE HAZY. NO BATCH INFORMATION CAN BE VIEWED IN EITHER OF THE PHOTOS PROVIDED. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A BD 100 PACK CARTON WAS RECEIVED IN GOOD CONDITION INSIDE OF A SHIPPING BOX WITH TISSUE PAPER. THERE WERE SEVENTY TUBES OUT OF ONE HUNDRED RECEIVED. FURTHER INSPECTION OF THE TUBES SHOWED NO SIGNS OF TURBIDITY. FOR FURTHER INVESTIGATION TWO RETURNS WERE TESTED. ONE TUBE WAS PLACED IN THE 33-TO-37-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED IN THE 20-TO-25-DEGREE CELSIUS INCUBATOR. NO MICROBIAL GROWTH OR TURBIDITY OF THE MEDIA WAS SEEN IN 2/2 INCUBATED RETURN TUBES AT SEVEN DAYS INCUBATION. THE MEDIA IN THE TUBES WAS ALSO PLATED ON TO TSA SHEEP BLOOD AGAR PLATES. NO MICROBIAL GROWTH WAS OBSERVED AFTER THE INCUBATED MEDIA WAS PLATED. THE COMPLAINT CANNOT BE CONFIRMED FROM THE RETENTION SAMPLES OR RETURNS FOR BATCH 0302188. BD WILL CONTINUE TO TREND FOR CONTAMINATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN TEST WAS USED TO CONFIRM THE CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOLLOW UP CALL PLACED TO CUSTOMER. CUSTOMER CONFIRMED RECEIPT OF BOX OF THIO BROTHS. CUSTOMER STATES THE BACILLUS SP. THEY FOUND IN THE TUBES WAS NOT REPORTED OUT FOR ANY PATIENTS AND NO ERRONEOUS RESULTS WERE ISSUED. NO PATIENT TREATMENT WAS AFFECTED. CUSTOMER IS REQUESTING REPLACEMENT FOR THE SECOND BOX OF BROTHS TUBES THEY RECEIVED SINCE THE ISSUE WAS IN BOTH BOXES. I LET CUSTOMER KNOW THAT THE SECOND BOX CAN BE REPLACED WHEN AND IF THE QUALITY INVESTIGATION IS CONFIRMED. IT WAS REPORTED THAT CUSTOMER HAS LARGE GRAM POSITIVE BACILLUS CONTAMINATION IN 221742 LOT 0302188 TUBES. CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN 221742 TUBES. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER CALLED IN REPORTING CONTAMINATION IN 221742 LOT 0302188 TUBES. THEY RECEIVED TWO BOXES OF THE TUBES AND TOWARDS THE END OF THE FIRST BOX USAGE THEY NOTICED SOME PATIENTS HAD GROWTH IN THE TUBES AFTER INCUBATION. THE GRAM STAIN SHOWED LARGE BOXCAR SHAPED GRAM POSITIVE BACILLUS. CUSTOMER OPENED SECOND BOX OF LOT NUMBER AND PLACED 30 TUBES THAT WERE UNINOCULATED INTO THE INCUBATOR FOR 8 DAYS. THEY PERFORMED GRAMS STAINS ON EACH AND FOUND 7 OF THE 30 TUBES HAD THE GPB PRESENT. PROBLEM WAS FIRST NOTICED ON (B)(6) 2021. THAT IS WHEN THE FIRST TUBE FROM THE FIRST BOX SHOWED THE GPB IN GRAM STAIN. TUBES ARE STORED IN REFRIGERATOR UPON RECEIPT UNTIL READY FOR USE ONCE RECEIVED IN LAB. CUSTOMER UNSURE IF THE TUBES ARE PLACE IN REFRIGERATOR IN SHIPPING DOC WHEN INITIALLY RECEIVED AT LOCATION OR LEFT OUT FOR ANY PERIOD OF TIME. SHE DOES STATE THERE ARE REFRIGERATORS IN THEIR SHIPPING DOC AREA WHICH SHOULD BE USED FOR REFRIGERATED MEDIA. REQUESTED CUSTOMER SEND IN REMAINDER OF SECOND BOX FOR QUALITY INVESTIGATION WHICH THEY AGREED TO. CUSTOMER ALSO AGREED TO TAKE PICTURES OF THE UNINOCULATED TUBES PRE AND POST INCUBATION AS THEY STATE THEY CAN SEE TINY PRECIPITATE IN THE TUBES. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN TEST WAS USED TO CONFIRM THE CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FOLLOW UP CALL PLACED TO CUSTOMER. CUSTOMER CONFIRMED RECEIPT OF BOX OF THIO BROTHS. CUSTOMER STATES THE BACILLUS SP. THEY FOUND IN THE TUBES WAS NOT REPORTED OUT FOR ANY PATIENTS AND NO ERRONEOUS RESULTS WERE ISSUED. NO PATIENT TREATMENT WAS AFFECTED. CUSTOMER IS REQUESTING REPLACEMENT FOR THE SECOND BOX OF BROTHS TUBES THEY RECEIVED SINCE THE ISSUE WAS IN BOTH BOXES. I LET CUSTOMER KNOW THAT THE SECOND BOX CAN BE REPLACED WHEN AND IF THE QUALITY INVESTIGATION IS CONFIRMED. IT WAS REPORTED THAT CUSTOMER HAS LARGE GRAM POSITIVE BACILLUS CONTAMINATION IN 221742 LOT 0302188 TUBES. CUSTOMER PROBLEM: CUSTOMER REPORTING CONTAMINATION IN 221742 TUBES. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER CALLED IN REPORTING CONTAMINATION IN 221742 LOT 0302188 TUBES. THEY RECEIVED TWO BOXES OF THE TUBES AND TOWARDS THE END OF THE FIRST BOX USAGE THEY NOTICED SOME PATIENTS HAD GROWTH IN THE TUBES AFTER INCUBATION. THE GRAM STAIN SHOWED LARGE BOXCAR SHAPED GRAM POSITIVE BACILLUS. CUSTOMER OPENED SECOND BOX OF LOT NUMBER AND PLACED 30 TUBES THAT WERE UNINOCULATED INTO THE INCUBATOR FOR 8 DAYS. THEY PERFORMED GRAMS STAINS ON EACH AND FOUND 7 OF THE 30 TUBES HAD THE GPB PRESENT. PROBLEM WAS FIRST NOTICED ON (B)(6) 2021. THAT IS WHEN THE FIRST TUBE FROM THE FIRST BOX SHOWED THE GPB IN GRAM STAIN. TUBES ARE STORED IN REFRIGERATOR UPON RECEIPT UNTIL READY FOR USE ONCE RECEIVED IN LAB. CUSTOMER UNSURE IF THE TUBES ARE PLACE IN REFRIGERATOR IN SHIPPING DOC WHEN INITIALLY RECEIVED AT LOCATION OR LEFT OUT FOR ANY PERIOD OF TIME. SHE DOES STATE THERE ARE REFRIGERATORS IN THEIR SHIPPING DOC AREA WHICH SHOULD BE USED FOR REFRIGERATED MEDIA. REQUESTED CUSTOMER SEND IN REMAINDER OF SECOND BOX FOR QUALITY INVESTIGATION WHICH THEY AGREED TO. CUSTOMER ALSO AGREED TO TAKE PICTURES OF THE UNINOCULATED TUBES PRE AND POST INCUBATION AS THEY STATE THEY CAN SEE TINY PRECIPITATE IN THE TUBES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627845 BD BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221742 0302188 30382902217429

    Patients

    Seq Age Sex Outcome Treatment
    1