BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 16140539 · Received January 11, 2023

    Report

    Report Number
    3008352382-2023-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. PMA/510K: K970512/K970333.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY . CATALOG 442288. BATCH NO. UNKNOWN . CUSTOMER REPORTED NO GROWTH DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. QUALITY CONTROL CERTIFICATES LISTS TEST ORGANISMS, INCLUDING ATCC¿ CULTURE SPECIFIED IN THE CLSI STANDARD M22, QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA FOR EXPECTED ATCC PERFORMANCE. COMPLAINT IS UNCONFIRMED. 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 WAS REPORTED THAT BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS FAILED TO GROW CANDIDA PARAPSILOSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE HAD AT LEAST FIVE SEPARATE BLOOD CULTURES POSITIVE FOR CANDIDA PARAPSILOSIS. THE QUANDRY IS THAT THE ORGANISM ONLY GREW IN THE AEROBIC BLOOD CULTURE BOTTLE AND FAILED TO GROW IN THE MYCOLYTIC BROTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS FAILED TO GROW CANDIDA PARAPSILOSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE HAD AT LEAST FIVE SEPARATE BLOOD CULTURES POSITIVE FOR CANDIDA PARAPSILOSIS. THE QUANDRY IS THAT THE ORGANISM ONLY GREW IN THE AEROBIC BLOOD CULTURE BOTTLE AND FAILED TO GROW IN THE MYCOLYTIC BROTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119137 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown