BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTO AGAR

    MDR report key: 11236950 · Received January 27, 2021

    Report

    Report Number
    1119779-2021-00146
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 15, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JSK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. RELEASE TESTING CONSISTS OF DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, SOLUTION APPEARANCE, PH, LOSS ON DRYING, ASH, CALCIUM, MAGNESIUM, MELTING POINT, GELATION POINT, RESIDUAL SOLVENTS, AND GROWTH PERFORMANCE WITH ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THIS TIME, THERE HAVE BEEN NO OTHER CONFIRMED COMPLAINTS ON THIS PRODUCT. NO INFORMATION WAS PROVIDED AS TO WHAT GROWTH ISSUES THE CUSTOMER WAS HAVING. PER A FOLLOW UP EMAIL ¿THE CUSTOMER HAS STATED THAT THEY DO NOT WISH TO LOG THIS AS A CUSTOMER COMPLAINT, HOWEVER WANTED TO KNOW IF BD HAD RECEIVED OR KNEW ABOUT ANY ISSUES WITH THIS MEDIA FROM OTHER CUSTOMERS OR NOT.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTO¿ AGAR ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THIS COULD LEAD TO TREATMENT OF A PATIENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE EFFECTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    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. (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9211130, MEDICAL DEVICE EXPIRATION DATE: 2024-05-31, DEVICE MANUFACTURE DATE: 2019-07-30. MEDICAL DEVICE LOT #: 0042227, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-02-11.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BACTO¿ AGAR ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THIS COULD LEAD TO TREATMENT OF A PATIENT WITH A LESS TOLERATED ANTIBIOTIC WHICH CAN LEAD TO SERIOUS ADVERSE EFFECTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131200 BD BACTO AGAR SUPPLEMENT, CULTURE MEDIA JSK BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0042227

    Patients

    Seq Age Sex Outcome Treatment
    1