BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO EGG YOLK ENRICHMENT 50%

    MDR report key: 11506442 · Received March 17, 2021

    Report

    Report Number
    1119779-2021-00500
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 22, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: MATERIAL 233472 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 9353002 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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 BATCH 9353002. RETENTION SAMPLES FROM BATCH 9353002 (6/6 BOTTLES) WERE AVAILABLE FOR INSPECTION. THREE OUT OF SIX RETENTION SAMPLES HAD SMALL BLACK PARTICLES OBSERVED WITHIN THE MEDIA. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. THE FIRST PHOTO SHOWS TWO BOTTLES; ONE OF THE BOTTLES SHOWS THE LABEL FROM BATCH 9353002 AND THE OTHER BOTTLE SHOWS THE MEDIA WITH WRITING ON THE BOTTLE. THE BOTTLE WITH THE LABEL VISIBLE THE MEDIA APPEARS TO HAVE BEEN USED. THE SECOND PHOTO SHOWS TWO BOTTLES WITH THE LABEL OF BOTH BOTTLES VERIFYING BOTH ARE FROM BATCH 9353002. THE LAST PHOTO SHOWS A CLOSE-UP OF THE TOP OF TWO BOTTLES. THERE IS DRIED, YELLOW COLORED MEDIA THAT THE TOP OF THE BOTTLES. FOREIGN MATERIAL OR BLACK PARTICLES WERE NOT SEEN IN THE MEDIA IN ANY OF THE PHOTOS PROVIDED. THE BLACK PARTICLES OBSERVED IN THE RETENTION SAMPLES ARE CONSISTENT WITH THE CAP MATERIAL WHICH CAN BE GROUND OR CHIPPED DURING THE CAPPING PROCESS. THE COMPLAINT CAN BE CONFIRMED BY THE RETENTION SAMPLES. BD WILL CONTINUE TO TREND COMPLAINTS FOR FOREIGN MATERIALS. BASED ON THE LOW DEFECT RATE FOR THIS BATCH, NO ACTIONS ARE PLANNED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD DIFCO¿ EGG YOLK ENRICHMENT 50% BLACK AND WHITE CONTAMINATION (POSSIBLY MOLD) WAS DISCOVERED IN 18 BOTTLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD DIFCO¿ EGG YOLK ENRICHMENT 50% BLACK AND WHITE CONTAMINATION (POSSIBLY MOLD) WAS DISCOVERED IN 18 BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402742 BD DIFCO EGG YOLK ENRICHMENT 50% CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL JSH BECTON, DICKINSON & CO. (SPARKS) 9353002

    Patients

    Seq Age Sex Outcome Treatment
    1