BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY BROTH

    MDR report key: 12351070 · Received August 20, 2021

    Report

    Report Number
    1119779-2021-01416
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 15, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    30382902218235
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO, CATALOG NUMBER 221823, TUBE TRYPTICASE SOY BROTH 15ML 100EA, BATCH NUMBER 1161592 FOR PHYSICAL DEFECTS AND CONTAMINATION. MATERIAL 221823 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 1161592 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FILLING, TORQUING, AUTOCLAVING AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED AT THE DESIGNATED INTERVALS. THOSE CHECKS CONFIRMED THAT THE CAPS WERE TIGHTENED TO THE VALIDATED SPECIFICATIONS PER INTERNAL PROCEDURE AND FILL VOLUMES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. 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 COMPLAINTS FOR BROKEN TUBES OR CONTAMINATION HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1161592 (10 TUBES) WERE AVAILABLE. THERE WAS NO EVIDENCE OF BROKEN OR CONTAMINATED TUBES OBSERVED IN 10/10 RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO UNINOCULATED RETENTION TUBES FROM BATCH 1161592 WERE PLACE INTO INCUBATION TO TEST FOR CONTAMINATION. ONE TUBE WAS PLACED INTO A 20-TO-25-DEGREE CELSIUS INCUBATOR AND ONE TUBE WAS PLACED IN A 33-TO-37-DEGREE CELSIUS INCUBATOR FOR SEVEN DAYS. AT SEVEN DAYS INCUBATION, THERE WAS NO MICROBIAL GROWTH OR TURBIDITY OBSERVED IN EITHER INCUBATED TUBES. FOUR PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS FIVE BD CARTONS. THE FOUR CARTONS APPEAR TO BE FROM BATCH 1161592. AN OPENED BD CARTON WAS PLACED ON TOP OF THE FOUR BD CARTONS. THE FLAP ON THE OPENED CARTON DOES APPEAR SLIGHTLY WARN. A TUBE RACK CAN BE OBSERVED FROM THE OPENED CARTON. THERE IS A TUBE IN THE CORNER OF ONE SIDE OF THE TUBE RACK THAT APPEARS BROKEN IN HALF. THERE IS BROKEN GLASS ALONG THE SIDE OF THE TUBE RACK TOWARDS THE OPENING OF THE CARTON. THE TUBES ARE FROM BATCH 1161592. THE SECOND PHOTO SHOWS A BD CARTON (CARTON NUMBER 036) FROM BATCH 1161592. THERE WAS A TUBE RACK PLACE ON TOP OF THE CARTON SHOWING EVIDENCE OF A BROKEN TUBE AND TWO CONTAMINATED TUBES. THE TUBES ARE FROM BATCH 1161592. THE THIRD PHOTO PLACES EMPHASIS ON FOUR TUBES, WHERE TWO TUBES APPEAR TO BE CONTAMINATED AND TWO ARE NOT. THE TUBES ARE FROM BATCH 1161592. THE LAST PHOTO SHOWS TUBES FROM THREE TUBE RACKS. THE TUBES ON THE BOTTOM DO NOT APPEAR TO HAVE BEEN BROKEN. THE TUBE RACK THAT WAS PLACED ON TOP OF THE OTHER TWO TUBE RACKS, SHOWS SEVEN TUBES ON THE SIDE OF THE TUBE RACK THAT APPEAR TO BE BROKEN. ALL TUBES APPEAR TO BE FROM BATCH 1161592. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CAN BE CONFIRMED BY THE PHOTOS PROVIDED. BD SHIPS PRODUCT IN TEMPERATURE CONTROLLED TRUCKS TO DISTRIBUTION CENTERS. DISTRIBUTION CENTERS ARE PROVIDED WITH SHIPPING AND STORAGE GUIDELINES. MISHANDLING OF THE PRODUCT AND VIBRATIONS DURING SHIPPING CAN CAUSE BROKEN TUBES. BASED ON THE LOW DEFECT RATE FOR THIS BATCH (B)(4), THERE ARE NO ACTIONS BEING TAKEN. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND BROKEN TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 15 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. 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 RECEIPT OF BROKEN AND CONTAMINATED MEDIA ITEM 221823- TUBE TRYPTICASE SOY BROTH - LOT 1161592. "

    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 15 BD BBL¿ TRYPTICASE¿ SOY BROTH CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. 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 RECEIPT OF BROKEN AND CONTAMINATED MEDIA ITEM 221823- TUBE TRYPTICASE SOY BROTH - LOT 1161592."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245929 BD BBL¿ TRYPTICASE¿ SOY BROTH CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 221823 1161592 30382902218235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown