BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 8851314 · Received August 1, 2019

    Report

    Report Number
    1111096-2019-00108
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 3, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSG
    UDI-DI
    00382902210931
    PMA / PMN Number
    PREAMEND.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS PRODUCT 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 9051900 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND AUTOCLAVE PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. PLEASE NOTE THAT DIRECT STAINING TECHNIQUES ARE NOT PART OF QC RELEASE TESTING FOR THIS PRODUCT AS NON-VIABLE ORGANISMS MAY BE PRESENT IN THE MEDIA. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE REVIEW OF ITS COLOR AND CLARITY. SAMPLES SUBMITTED ARE EXAMINED TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. THE APPEARANCE OF THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED AND NO OTHER COMPLAINTS HAVE BEEN TAKEN FOR PERFORMANCE BUT THIS CUSTOMER DOES HAVE ANOTHER COMPLAINT FOR CLARITY. RETENTION SAMPLES FROM BATCH 9051900 (10 TUBES) WERE AVAILABLE FOR INSPECTION. NO CAP, TUBE OR MEDIA DEFECTS WERE OBSERVED IN THE RETENTION SAMPLES. THE CLARITY SPECIFICATION FOR THIS PRODUCT IS CLEAR TO TRACE HAZY. THE RETENTION SAMPLES WERE SATISFACTORY FOR APPEARANCE. RETURNS WERE RECEIVED FOR INVESTIGATION. ONE HUNDRED TUBES FROM BATCH 9051900 WERE RETURNED IN A 100PACK CARTON (#312) IN AN INSULATED BOX WITH ICE PACKS AND AIR BUBBLES. NO CAP, TUBE OR MEDIA DEFECTS WERE OBSERVED IN 100/100 RETURNED TUBES. FOR INVESTIGATION OF THIS COMPLAINT, RETURN AND RETENTION TUBES WERE TESTED AS DESCRIBED IN THE CERTIFICATE OF ANALYSIS AND ALL ORGANISMS HAD GROWTH WITHIN THE SPECIFIED TIME AS EXPECTED. NO PERFORMANCE DEFECTS WERE OBSERVED IN THE RETURNS AND RETENTION SAMPLES TESTED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE IS UNDETERMINED, COULD NOT REPLICATE PERFORMANCE FAILURE. BASED ON BATCH TREND DATA FOR THIS DEFECT, NO CORRECTIVE ACTION IS INDICATED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THE CUSTOMER ALLEGED THAT THE MEDIA WAS DEFECTIVE AND WAS CAUSING NON-SPECIFIC ISSUES WITH CULTURING AND PROCESSING TISSUES. THE CUSTOMER INDICATED THE USE OF THE MEDIA RESULTED IN DISCREPANT RESULTS AND LOSS OF DONOR TISSUE. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED. THREE ATTEMPTS WERE MADE TO FOLLOW-UP FOR ADDITIONAL INFORMATION WITHOUT A RESPONSE.

    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 WHILE USING BD BBL¿ TRYPTICASE¿ SOY BROTH THE CUSTOMER ALLEGED THAT THE MEDIA WAS DEFECTIVE AND WAS CAUSING NON-SPECIFIC ISSUES WITH CULTURING AND PROCESSING TISSUES. THE CUSTOMER INDICATED THE USE OF THE MEDIA RESULTED IN DISCREPANT RESULTS AND LOSS OF DONOR TISSUE. NO INFORMATION WAS AVAILABLE ON HOW THE PATIENT TREATMENT WAS CHANGED OR IF TREATMENT WAS CHANGED. NO MISDIAGNOSIS OR WORSENING IN PATIENT CONDITION WAS INDICATED. THREE ATTEMPTS WERE MADE TO FOLLOW-UP FOR ADDITIONAL INFORMATION WITHOUT A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647728 BD BBL¿ TRYPTICASE¿ SOY BROTH MULTIPURPOSE CULTURE MEDIUM JSG BECTON, DICKINSON & CO. 9051900 00382902210931

    Patients

    Seq Age Sex Outcome Treatment
    1 Other