BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT

    MDR report key: 12229324 · Received July 27, 2021

    Report

    Report Number
    1119779-2021-01220
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 28, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    30382904421534
    PMA / PMN Number
    K920933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BACTEC FOS SUPPLEMENT KIT (442153) BATCH 1082476 IS COMPOSED OF FOS SUPPLEMENT BATCH 1021760 AND FOS RECONSTITUTION FLUID BATCH 1014941. BATCH HISTORY RECORD REVIEW FOR BACTEC FOS SUPPLEMENT KIT BATCH 1082476 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAVE BEEN TAKEN ON THIS KIT BATCH FOR PERFORMANCE. 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. TUBES 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). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTION SAMPLES OF FOS SUPPLEMENT BATCH 1021760 (10 VIALS) WERE AVAILABLE FOR INSPECTION. NO CRIMP, VIAL OR MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION VIALS. LIKEWISE, RETENTION SAMPLES OF FOS RECONSTITUTION FLUID BATCH 1014941 (8/8 VIALS) HAD NO OBSERVABLE DEFECTS FROM VISUAL INSPECTION. AS A COURTESY TO THE CUSTOMER, THE RETENTIONS WERE TESTED. ONE RETENTION FOS RECONSTITUTION FLUID BATCH 1014941 WAS USED TO RECONSTITUTE ONE RETENTION BACTEC FOS SUPPLEMENT VIAL FROM BATCH 1021760. THE FLUID APPEARED AS THE PACKAGE INSERT INSTRUCTED FOR RETENTION SAMPLE, THE SUPPLEMENT VIALS HAD A TURBID APPEARANCE. THE VIALS WERE THEN PLACED INTO THE 33-37 DEGREE C INCUBATOR FOR 7 DAYS. AT THE END OF THE 7 DAYS NO MICROBIAL GROWTH WAS SEEN THE RETENTION VIAL. THE FLUID WAS FURTHER TEST FOR GROWTH BY PLATING THE FLUID ON TSA SHEEP BLOOD AGAR. NEITHER THE INCUBATED FLUID NOR THE PLATED FLUID SHOWED SIGNS OF MICROBIAL GROWTH. THE PACKAGE INSERT FOR THIS PRODUCT DOES INDICATE THAT MEDIA CONTAINING FOS WILL APPEAR SLIGHTLY TURBID. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLIANT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR APPEARANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 4 BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT 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: "NOTICEABLE CLOUDINESS ON 4 TUBES, DISCARDED AND NOT USED".

    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 4 BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT 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: " NOTICEABLE CLOUDINESS ON 4 TUBES, DISCARDED AND NOT USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127671 BD BACTEC¿ FOS¿ (FASTIDIOUS ORGANISM SUPPLEMENT) KIT SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 442153 1082476 30382904421534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown