BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT

    MDR report key: 22952953 · Received September 3, 2025

    Report

    Report Number
    1119779-2025-04894
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 10, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382904375196
    PMA / PMN Number
    K920933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BACTEC FOS SUPPLEMENT IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC FOS RECONSTITUTION FLUID IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENOUS SOLUTION IS OBTAINED. THE SOLUTION IS DISPENSED INTO VIALS AND CAPPED AND CRIMPED PER SOP. VIALS ARE AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE; PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, VIALS ARE LABELED AND PACKAGED IN A SEPARATE PACKING AREA. FOUR FOS SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE FOS RECONSTITUTION FLUID VIAL TO MAKE A BACTEC FOS SUPPLEMENT KIT (MATERIAL 442153). BACTEC FOS SUPPLEMENT KIT BATCH 4059819 IS COMPOSED OF FOS SUPPLEMENT BATCH 4040250 AND FOS RECONSTITUTION FLUID BATCH 4011793. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 WAS SATISFACTORY. NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. BATCH HISTORY RECORD REVIEWS FOR FOS SUPPLEMENT BATCH 4040250 AND FOS RECONSTITUTION FLUID BATCH 4011793 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 WAS SATISFACTORY. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN EITHER BATCH. THERE WERE NO PHOTOS OR RETURNS SUBMITTED TO ASSIST WITH THIS INVESTIGATION. RETENTIONS OF BATCH 4011793 (RECONSTITUTION FLUID) AND RETENTIONS OF BATCH 4040250 (FOS SUPPLEMENT) WERE AVAILABLE AND USED FOR FURTHER INVESTIGATION. THERE WERE NO OBSERVED DEFECTS IN THE AVAILABLE RETENTIONS. TWO FOS SUPPLEMENT VIALS WERE RECONSTITUTED WITH TWO RECONSTITUTION FLUID VIALS AND INCUBATED FOR 7 DAYS. ONE WAS PLACED INTO 20-25 DEGREE C INCUBATION, AND ONE WAS PLACED INTO 33-37 DEGREE C INCUBATION. GROWTH WAS OBSERVED IN THE 33-37C SAMPLE AFTER INCUBATION. THE SAMPLE WAS SUBCULTURED ONTO TSA AND SDA PLATES AND SUBMITTED FOR ID. NO VIABLE GROWTH WAS RECOVERED. THIS COMPLAINT FOR BACTEC FOS SUPPLEMENT KIT BATCH 4059819 CAN BE CONFIRMED FOR CONTAMINATION. NO COMPLAINT TRENDS FOR THIS DEFECT HAVE BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND FOR DEFECTS. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT, THE CUSTOMER FOUND CONTAMINATION IN AN UNKNOWN QUANTITY OF MEDIA DURING QUALITY CONTROL TESTING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386536 BD BACTEC¿ FOS¿ CULTURE SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 4059819 30382904375196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown