BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS

    MDR report key: 13389083 · Received January 28, 2022

    Report

    Report Number
    2647876-2022-00015
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 1, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904421922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: K921133 , K083572. 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

    H.6. 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 THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS HAS BEEN FOUND PRODUCING FALSE POSITIVE RESULTS. SUB-CULTURING WAS PERFORMED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE MICROBIAL GROWTH TEST (ALL VIALS).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS HAS BEEN FOUND PRODUCING FALSE POSITIVE RESULTS. SUB-CULTURING WAS PERFORMED FOR CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FALSE-POSITIVE MICROBIAL GROWTH TEST (ALL VIALS)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363387 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442192 1188582 00382904421922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown