BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 13636877 · Received March 1, 2022

    Report

    Report Number
    3008352382-2022-00002
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 21, 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
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER CLAIM A FALSE POSITIVE DEFECT. PLOTS AND PHOTOS WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. NO INVESTIGATION CAN BE CONDUCTED TO THE RETENTION SAMPLES. 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. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO 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. DO NOT USE CULTURE VIALS PAST THEIR EXPIRATION DATE. COMPLAINT IS UNCONFIRMED. PLOTS PROVIDED DID NOT SHOWED A GROWTH CURVE. NO CORRECTIVE 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 INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), 7 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY GRAM TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 7 VIALS OF LOT 1132356 WERE INDICATED AS POSITIVE BY THE EQUIPMENT AND WHEN PERFORMING THE GRAM STAIN, NO MICROORGANISMS WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), 7 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY GRAM TESTING WAS PERFORMED, AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 7 VIALS OF LOT 1132356 WERE INDICATED AS POSITIVE BY THE EQUIPMENT AND WHEN PERFORMING THE GRAM STAIN, NO MICROORGANISMS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992956 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 1132356 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown