BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ EY TELLURITE ENRICHMENT

    MDR report key: 17494670 · Received August 9, 2023

    Report

    Report Number
    1119779-2023-00864
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 5, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: DEVICE AVAILABLE FOR EVAL? YES RETURNED TO MANUFACTURER ON: 07/27/2023. H.6 INVESTIGATION SUMMARY: MATERIAL 277910 IS PREPARED USING A CONCENTRATED EGG YOLK EMULSION. THE EGGS ARE CLEANED, CRACKED, AND SEPARATED BY HAND. ALTHOUGH THE EGG CRACKING PROCESS IS NOT STERILE OR PERFORMED IN A STERILE ENVIRONMENT, THE PROCESS WAS DEVELOPED TO MINIMIZE BIOBURDEN IN THE EGG YOLK PROCESS. THE EMULSION IS MIXED PER STANDARD OPERATING PROCEDURE (SOP). FILLING AND CAPPING ARE PERFORMED WITHIN THE ASEPTIC PROCESSING AREA. THE MEDIA IS MANUALLY DISPENSED INTO HEAT PROCESSED BOTTLES. CAPS ARE PLACED MANUALLY ON THE BOTTLES AND HAND TIGHTENED. PRODUCT IS TORQUED BY MACHINE LABELED. BOTTLES ARE INSPISSATED USING A VALIDATED CYCLE AND THEN PACKAGED IN A SEPARATE PACKING AREA. THE BATCH HISTORY RECORD REVIEW FOR BATCH 2208262 WAS SATISFACTORY PER INTERNAL PROCEDURES. FORMULATION AND FILLING 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. 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. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 2208262 (6/6 BOTTLES) WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS OR CONTAMINATION WAS OBSERVED IN 6/6 RETENTION SAMPLES. FOR FURTHER INVESTIGATION TWO BOTTLES WENT INTO INCUBATION. ONE BOTTLE WENT INTO 20-25-DEGREES CELSIUS, AND ONE BOTTLE WENT INTO 33-37-DEGREES CELSIUS. AT SEVEN-DAYS INCUBATION NO MICROBIAL GROWTH WAS OBSERVED IN 2/2 INCUBATED RETENTION BOTTLES. FOUR PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A PLATE IN THE PLASTIC PACKAGING. THE PLATE IS NOT A BD PRODUCT. THERE DOES APPEAR TO BE MOLD ON THE PLATE. THE SECOND PHOTO SHOWS A PLATE WITH MOLD ON IT AND WRITTEN ON THE PLATE IS EGG YOLK. NO PRODUCT INFORMATION IS PRESENTED IN THE PHOTO. THE THIRD PHOTO SHOWS A PLATE IN THE PLASTIC PACKAGING. THERE DOES APPEAR TO BE MOLD ON THE PLATE. THE LAST PHOTO ALSO SHOWS A PLATE WITH MOLD ON IT AND EGG YOLK WRITTEN ON THE PLATE. NO PRODUCT INFORMATION IS PRESENTED IN THE PHOTO. RETURNS WERE ALSO SENT TO ASSIST WITH THE INVESTIGATION. A SMALL SHIPPING BOX WITH TISSUE PAPER AND BUBBLE WRAP WAS RECEIVED WITH A BD CARTON FROM BATCH 2208262 (6 BOTTLES). ALL 6/6 RETURN BOTTLES WERE RECEIVED IN GOOD CONDITION WITH NO EVIDENCE OF MOLDED CONTAMINATION. FOR FURTHER INVESTIGATION THREE RETURN BOTTLES WERE PLACED INTO 33-37-DEGREES CELSIUS AND THREE RETURN BOTTLES WERE PLACED INTO 20-25-DEGREES CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN 6/6 INCUBATED RETURN BOTTLES. TWO BOTTLES WERE POURED INTO PETRI DISHES. ONE DISH WAS INCUBATED AT 20-25-DEGREES CELSIUS, AND ONE DISH WAS INCUBATED AT 33-37-DEGREES CELSIUS. AT THE END OF A FOUR-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED IN EITHER PETRI DISH. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD DIFCO EY TELLURITE ENRICHMENT THE BOTTLES WERE DISCOVERED TO BE CONTAMINATED, THEY WERE SUBCULTURED AND MOLD WAS RECOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION OF #277910_2208262 THE ISSUE WAS NOT IDENTIFIED AT THE TIME OF RECEIPT, THE UNOPENED BOTTLES WERE SUBCULTURED AND MOLD WAS RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD DIFCO EY TELLURITE ENRICHMENT THE BOTTLES WERE DISCOVERED TO BE CONTAMINATED, THEY WERE SUBCULTURED AND MOLD WAS RECOVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CONTAMINATION OF #(B)(4). THE ISSUE WAS NOT IDENTIFIED AT THE TIME OF RECEIPT, THE UNOPENED BOTTLES WERE SUBCULTURED AND MOLD WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013581 BD DIFCO¿ EY TELLURITE ENRICHMENT SUPPLEMENT, CULTURE MEDIA JSK BECTON DICKINSON & CO. (SPARKS) 2208262

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown