BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MIDDLEBROOK ADC ENRICHMENT

    MDR report key: 11338246 · Received February 17, 2021

    Report

    Report Number
    1119779-2021-00318
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL 211887 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED, AND THE SOLUTION IS THEN STERILE FILTERED. TUBES ARE FILLED, CAPPED AND TORQUED PER STANDARD OPERATING PROCEDURES (SOP). TUBES ARE THEN SENT TO A SEPARATE PACKAGING AREA FOR LABELING AND TO BE PACKED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEWS FOR BATCHES 0051664 AND 9346056 WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED FOR BATCHES 9346056 AND 0051664 AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON EACH BATCH FOR PERFORMANCE (BUT ARE ALSO NOT CONFIRMED). RETENTION SAMPLES FROM BATCHES 0051664 AND 9346056 (10 TUBES EACH) WERE AVAILABLE. NO CAP, TUBE OR MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION TUBES FROM BATCH 0051664 AND 10/10 RETENTION TUBES FROM BATCH 9346056 FROM VISUAL INSPECTION. IT IS NOTED THAT THIS COMPLAINT WAS TAKEN ON JANUARY 27, 2021. BATCH 0051664 EXPIRED ON 2020-10-19 AND BATCH 9346056 EXPIRED ON 2020-08-04. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. RETENTION SAMPLES COULD NOT BE TESTED FOR THIS INVESTIGATION. NO PHOTOS OR RETURNS WERE RECEIVED FROM THE CUSTOMER. THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MIDDLEBROOK ADC ENRICHMENT THE BACTERIA DID NOT DEVELOP AT NORMAL RATE WHEN THIS SUPPLEMENT WAS ADDED. THIS OCCURRED WITH 10 UNITS FROM EACH LOT#. THE PATIENT IMPACT WAS NOT REPORTED.

    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 #: 9346056, MEDICAL DEVICE EXPIRATION DATE: 2020-08-04, DEVICE MANUFACTURE DATE: 2019-12-12. MEDICAL DEVICE LOT #: 0051664, MEDICAL DEVICE EXPIRATION DATE: 2020-10-19, DEVICE MANUFACTURE DATE: 2020-02-20. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BBL¿ MIDDLEBROOK ADC ENRICHMENT THE BACTERIA DID NOT DEVELOP AT NORMAL RATE WHEN THIS SUPPLEMENT WAS ADDED. THIS OCCURRED WITH 10 UNITS FROM EACH LOT#. THE PATIENT IMPACT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235876 BD BBL MIDDLEBROOK ADC ENRICHMENT SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1