BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 12097054 · Received June 30, 2021

    Report

    Report Number
    1119779-2021-01104
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 3, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902217160
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-11-09. INVESTIGATION SUMMARY: MATERIAL 221716 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 1070131 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WAS SATISFACTORY AT TIME OF RELEASE. DIRECT STAINING TECHNIQUES ARE NOT PART OF QC RELEASE TESTING FOR THIS PRODUCT. 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 TWO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. RETENTION SAMPLES FROM BATCH 1070131 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CAP, TUBE OR MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. ALL RETENTIONS TUBES HAD THE EXPECTED APPEARANCE FOR THIS PRODUCT OF LIGHT TO MEDIUM LIGHT YELLOW, TRACE HAZY TO CLEAR. FOR FURTHER INVESTIGATION, TWO RETENTION TUBES FROM BATCH 1070131 WERE TESTED FOR CONTAMINATION. ONE RETENTION TUBE WAS INCUBATED AT 20-25 DEGREES C AND ANOTHER RETENTION TUBE WAS PLACED IN THE 33-37 DEGREES C INCUBATOR. AT 7 DAYS INCUBATION, THERE WAS NO MICROBIAL GROWTH OR TURBIDITY IN EITHER RETENTION TUBE. ONE PHOTO WAS RECEIVED TO ASSIST WITH THE INVESTIGATION: THE PHOTO SHOWS THREE TUBES FROM BATCH 1070131. THE MEDIA IN TWO TUBES FROM THE PHOTO DOES APPEARS TURBID. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A BD CARTON (CARTON NUMBER 0327) WAS RECEIVED IN A SHIPPING BOX WITH NINETY-FIVE TUBES FROM 1070131. THERE WAS NO EVIDENCE OF CONTAMINATION OR TURBIDITY OBSERVED FROM 95/95 RETURNED TUBES. HOWEVER, THERE WAS SEDIMENTATION OBSERVED IN 95/95 RETURNED TUBES. FOR FURTHER INVESTIGATION TWO TUBES WERE PLATED ONTO TWO 5% TSA SHEEP BLOOD MEDIA. ONE PLATE WAS PLACED INTO THE 33-27-DEGREE CELSIUS INCUBATOR AND ONE PLATE WAS PLACED INTO THE 20¿25-DEGREE CELSIUS INCUBATOR FOR SEVEN DAYS NO MICROBIAL GROWTH WAS OBSERVED. FOR ADDITIONAL INVESTIGATION, TWO RETURN TUBES FROM BATCH 1070131 WERE TESTED FOR CONTAMINATION. ONE RETURN TUBE WAS INCUBATED AT 20-25 DEGREES CELSIUS, AND ANOTHER RETURN TUBE WAS PLACED IN THE 33-37 DEGREES CELSIUS INCUBATOR. AT 7 DAYS INCUBATION, THERE WAS NO MICROBIAL GROWTH OR TURBIDITY IN EITHER RETENTION TUBE. THE MEDIA WAS ALSO PLATED ON 5% SHEEP BLOOD MEDIA AND NO GROWTH WAS OBSERVED ON THE PLATES.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " IT WAS REPORTED THAT CUSTOMER REPORTING CONTAMINATION IN 221716 TUBES LOT 1070131. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " IT WAS REPORTED THAT CUSTOMER REPORTING CONTAMINATION IN 221716 TUBES LOT 1070131 "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988172 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221716 1070131 30382902217160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown