BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL MIDDLEBROOK ADC ENRICHMENT

    MDR report key: 11619949 · Received April 6, 2021

    Report

    Report Number
    1119779-2021-00615
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 BATCH 0051664 WAS 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 BATCH 0051664 AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS BATCH FOR PERFORMANCE (BUT IS ALSO NOT CONFIRMED). RETENTION SAMPLES FROM BATCH 0051664 WERE NOT AVAILABLE FOR VISUAL INSPECTION. IT IS NOTED THAT THIS COMPLAINT WAS TAKEN ON MARCH 15, 2021. BATCH 0051664 EXPIRED ON 2020-10-19. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS. 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 ATYPICAL GROWTH 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: "IT SEEMS THAT SOMETHING WAS WRONG WITH LOT NUMBER 0051664 (211887). BACTERIA DID NOT GROW AT THEIR NORMAL RATE WHEN ADDING THIS SUPPLEMENT. THE PERFORMANCE WAS NOT THE EXPECTED ONE AND THE CUSTOMER CLAIMS THAT THEY HAVE SPENT MUCH TIME AND SEVERAL OTHER ITEMS, WHICH THEY HAD TO THROW AWAY DUE TO THE BAD RESULTS THEY GOT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD (B)(6) ADDRESS USED. 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 BD BBL¿ MIDDLEBROOK ADC ENRICHMENT ATYPICAL GROWTH 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: "IT SEEMS THAT SOMETHING WAS WRONG WITH LOT NUMBER 0051664 (211887). BACTERIA DID NOT GROW AT THEIR NORMAL RATE WHEN ADDING THIS SUPPLEMENT. THE PERFORMANCE WAS NOT THE EXPECTED ONE AND THE CUSTOMER CLAIMS THAT THEY HAVE SPENT MUCH TIME AND SEVERAL OTHER ITEMS, WHICH THEY HAD TO THROW AWAY DUE TO THE BAD RESULTS THEY GOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522730 BD BBL MIDDLEBROOK ADC ENRICHMENT SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 0051664

    Patients

    Seq Age Sex Outcome Treatment
    1