BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT

    MDR report key: 19115473 · Received April 16, 2024

    Report

    Report Number
    1119779-2024-00293
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 22, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382904421534
    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

    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

    INVESTIGATION SUMMARY: BACTEC FOS SUPPLEMENT KIT BATCH 3249737 IS COMPOSED OF FOS SUPPLEMENT BATCH 3214672 AND FOS RECONSTITUTION FLUID BATCH 3214676. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 3249737 WAS SATISFACTORY. NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. 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). BATCH HISTORY RECORD REVIEWS FOR FOS SUPPLEMENT BATCH 3214672 AND FOS RECONSTITUTION FLUID BATCH 3214676 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. NO OTHER COMPLAINTS HAVE BEEN TAKEN EITHER BATCH. RETENTIONS OF BATCH 3214676 (RECONSTITUTION FLUID) WERE NOT AVAILABLE; HOWEVER, BATCH 3214672 (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 STERILE WATER AND INCUBATED FOR 7 DAYS. ONE WAS PLACED INTO 20-25 DEGREE C INCUBATION, AND ONE WAS PLACED INTO 33-37 DEGREE C INCUBATION. THERE WAS NO GROWTH OBSERVED AFTER INCUBATION. THERE WERE NO PHOTOS OR RETURNS SUBMITTED TO ASSIST WITH THIS INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT BIOLOGICAL CONTAMINATION WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT BIOLOGICAL CONTAMINATION WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690920 BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON & CO. (SPARKS) 3249737 30382904421534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown