BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12308388 · Received August 11, 2021

    Report

    Report Number
    2647876-2021-00027
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    July 15, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER REPORTED A FALSE POSITIVE DEFECT. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. USERS ARE CAUTIONED IN THE PACKAGE INSERT UNDER LIMITATION OF THE PROCEDURE: ¿A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBER OF NON-VIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDE AND SPECIMENS USED FOR INOCULATION. THERE ARE MANY FACTORS THAT CAN INFLUENCE THE FALSE POSITIVE RATE, INCLUDING BLOOD VOLUME, BLOOD CELL COUNTS, ENVIRONMENTAL FACTORS, AND MEDIA LOT TO LOT VARIATIONS. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW. NO CORRECTIVES ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE HAS BEEN AN INCREASE IN FALSE POSITIVES. CONFIRMATORY GRAM STAINING WAS PERFORMED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER OF KPJ BANDAR MAHARANI THAT OF LATE THEY NOTICED THAT THERE IS AN INCREASE IN THE FALSE POSITIVE CASES ON THE BACTEC 9120 (BOW). IN JUNE 13-21, THE TOTAL CULTURE WAS 63 AND THERE WAS 3 FALSE POSITIVES. FOLLOWING THE CALCULATION (QTY OF FALSE POSITIVE BOTTLES/QTY OF NEGATIVE BOTTLES), WE CAN SEE THAT IT HAS EXCEEDED THE FALSE POSITIVE ACCEPTANCE CRITERIA, WHICH IS 5%. ONCE TRIGGERED AS POSITIVES, THE CUSTOMER PERFORMED GRAM STAINING, AS WELL AS SUBCULTURE ON BA AND MACCONKEY PLATE. THE OUTCOME ON THESE WERE NOS. ACCORDING TO THE CUSTOMER, SHE CONFIRMED THAT THESE PATIENTS HAVE NORMAL WBC, THEY ARE NOT ON CHEMOTHERAPY DRUGS, NO POWER FAILURE OR ANY ABNORMAL TEMPERATURE ALERT. "

    Additional Manufacturer Narrative · 1

    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 WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE HAS BEEN AN INCREASE IN FALSE POSITIVES. CONFIRMATORY GRAM STAINING WAS PERFORMED. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE RECEIVED A COMPLAINT FROM OUR CUSTOMER OF (B)(6) THAT OF LATE THEY NOTICED THAT THERE IS AN INCREASE IN THE FALSE POSITIVE CASES ON THE BACTEC 9120 (BOW). IN (B)(6) 2021, THE TOTAL CULTURE WAS 63 AND THERE WAS 3 FALSE POSITIVES. FOLLOWING THE CALCULATION (QTY OF FALSE POSITIVE BOTTLES/QTY OF NEGATIVE BOTTLES), WE CAN SEE THAT IT HAS EXCEEDED THE FALSE POSITIVE ACCEPTANCE CRITERIA, WHICH IS 5%. ONCE TRIGGERED AS POSITIVES, THE CUSTOMER PERFORMED GRAM STAINING, AS WELL AS SUBCULTURE ON BA AND MACCONKEY PLATE. THE OUTCOME ON THESE WERE NOS. ACCORDING TO THE CUSTOMER, SHE CONFIRMED THAT THESE PATIENTS HAVE NORMAL WBC, THEY ARE NOT ON CHEMOTHERAPY DRUGS, NO POWER FAILURE OR ANY ABNORMAL TEMPERATURE ALERT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203841 BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1025363 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1