BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

    MDR report key: 13254505 · Received January 13, 2022

    Report

    Report Number
    2647876-2021-00390
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 22, 2021
    Report Date
    February 15, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1245120, MEDICAL DEVICE EXPIRATION DATE: 2022-6-30, DEVICE MANUFACTURE DATE: 2021-09-02. MEDICAL DEVICE LOT #: 1273772, MEDICAL DEVICE EXPIRATION DATE: 2022-7-31, DEVICE MANUFACTURE DATE: 2021-09-30. MEDICAL DEVICE LOT #: 1181333, MEDICAL DEVICE EXPIRATION DATE: 2022-4-30, DEVICE MANUFACTURE DATE: 2021-06-30. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: 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. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE 'AS REPORTED' DEFECT CODE. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS, THERE WERE SIX OCCURRENCES OF OBTAINING FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTING FALSE POSITIVE BOTTLES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT WHILE TESTING WITH BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS, THERE WERE SIX OCCURRENCES OF OBTAINING FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER REPORTING FALSE POSITIVE BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784316 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS AEROBIC BLOOD CULTURE BROTH MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H.10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown