BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO EY TELLURITE ENRICHMENT

    MDR report key: 11509532 · Received March 17, 2021

    Report

    Report Number
    1119779-2021-00503
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 22, 2021
    Report Date
    September 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    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

    INVESTIGATION SUMMARY: THIS PRODUCT 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 AND THEN LABELED. BOTTLES ARE INSPISSATED USING A VALIDATED CYCLE AND THEN PACKAGED IN A SEPARATE PACKING AREA. THE BATCH HISTORY RECORD REVIEW FOR BATCHES 9190511, AND 0252008 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE BATCH HISTORY RECORD REVIEW FOR BATCH 0204965 WAS SATISFACTORY PER INTERNAL PROCEDURES. THE 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 ANY OF THESE BATCHES. BATCH 9190511 RETENTION SAMPLES FROM BATCH 9190511 (6/6 BOTTLES) WERE AVAILABLE FOR INSPECTION. AFTER INVESTIGATION OF THE RETENTION BOTTLES 4/6 BOTTLES HAD TINY BLACK PARTICLES OBSERVED WITHIN THE MEDIA, HOWEVER, THERE WAS NO EVIDENCE OF MOLD. NO OTHER OBSERVATIONS WERE MADE FROM THE RETENTION BOTTLES. BATCH 0204965 RETENTION SAMPLES FROM BATCH 0204965 (6/6 BOTTLES) WERE AVAILABLE FOR INSPECTION. AFTER INVESTIGATION OF THE RETENTION BOTTLES THERE WAS NO EVIDENCE OF MOLD OR BLACK PARTICLES IN THE MEDIA, FROM VISUAL INSPECTION OF 6/6 BOTTLES. NO OTHER OBSERVATIONS WERE MADE FROM THE RETENTION BOTTLES. BATCH 0252008 RETENTION SAMPLES FROM BATCH 0252008 (6/6 BOTTLES) WERE AVAILABLE FOR INSPECTION. AFTER INVESTIGATION OF THE RETENTION BOTTLES THERE WAS NO EVIDENCE OF BLACK PARTICLES OR MOLD IN 6/6 BOTTLES WITHIN THE MEDIA. NO OTHER OBSERVATIONS WERE MADE FROM THE RETENTION BOTTLES. THREE PHOTOS WERE RECEIVED IN LIEU OF RETURNS TO ASSIST WITH THE INVESTIGATION. THE FIRST PHOTO SHOWS TWO BOTTLES FROM BATCH 9190511. THE BOTTLE ON THE LEFT THE CUSTOMER WROTE OPEN ON THE LABEL AND THIS BOTTLE DOES APPEAR TO HAVE BEEN USED. THE BOTTLE ON THE RIGHT APPEARS UNUSED. FROM THIS PHOTO, BLACK PARTICLES OR MOLD CANNOT BE OBSERVED. THE SECOND PHOTO SHOWS THAT THE BOTTLE ON THE LEFT BEING HELD UP TO SHOW WHAT APPEARS TO BE A TINY BLACK PARTICLE AT THE BOTTOM OF THE BOTTLE. THE THIRD PHOTO SHOWS A CLOSEUP OF THE BOTTOM OF THE BOTTLE ON THE RIGHT AND TWO BLACK PARTICLES CIRCLED ON THE BOTTOM OF THE BOTTLE. THERE ARE NO PHOTOS TO ASSIST WITH THE INVESTIGATION FOR BATCHES 0204965 OR 0252008. WITHOUT PHOTOS OR RETURNS THE COMPLAINT CANNOT BE VERIFIED OR CONFIRMED. THE BLACK PARTICLES OBSERVED IN THE RETENTION SAMPLES AND FROM THE PHOTOS OF BATCH 9190511 APPEAR THE SAME AND THOSE PARTICLES ARE CONSISTENT WITH THE CAP MATERIAL WHICH CAN BE GROUND OR CHIPPED DURING THE CAPPING PROCESS. THE COMPLAINT BE CONFIRMED, FOR FOREIGN MATERIAL, BY THE RETENTION SAMPLES AND PHOTO FOR BATCH 9190511. THE COMPLAINT FOR BATCHES 0204965 AND 0252008 CANNOT BE CONFIRMED. THERE ARE NO FURTHER ACTIONS PLANNED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR FOREIGN MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD DIFCO¿ EY TELLURITE ENRICHMENT BLACK AND WHITE CONTAMINATION (POSSIBLY MOLD) WAS DISCOVERED. THIS OCCURRED WITH 5 BOTTLES OF LOT# 9190511, 9 BOTTLES OF LOT# 0252008, AND 3 BOTTLES OF LOT# 0204965.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9190511, MEDICAL DEVICE EXPIRATION DATE: 2021-07-03, DEVICE MANUFACTURE DATE: 2019-07-09. MEDICAL DEVICE LOT #: 0252008, MEDICAL DEVICE EXPIRATION DATE: 2022-09-09, DEVICE MANUFACTURE DATE: 2020-09-08. 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¿ EY TELLURITE ENRICHMENT BLACK AND WHITE CONTAMINATION (POSSIBLY MOLD) WAS DISCOVERED. THIS OCCURRED WITH 5 BOTTLES OF LOT# 9190511, 9 BOTTLES OF LOT# 0252008, AND 3 BOTTLES OF LOT# 0204965.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404938 BD DIFCO EY TELLURITE ENRICHMENT SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 0204965

    Patients

    Seq Age Sex Outcome Treatment
    1