BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 11579804 · Received March 27, 2021

    Report

    Report Number
    3008352382-2021-00097
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 27, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. BD BACTEC SYSTEM IS DESIGNED AND CLEARED FOR THE QUALITATIVE CULTURE AND RECOVERY OF ANAEROBIC/AEROBIC ORGANISMS FROM BLOOD. BD HAS NO SPECIFICATION FOR USE WITH MOLECULAR TESTING SUCH AS THE BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. WHILE BD HIGHLIGHTS THE INHERENT RISK OF NONVIABLE ORGANISMS IN BLOOD CULTURE MEDIA IN OUR PACKAGE INSERT IS STATED THE MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURES¿ INSTRUCTIONS FOR USE. ALTHOUGH BD IS UNABLE TO CONFIRM THE COMPLAINT, WE HAVE INITIATED CAPA # 2631844 TO FURTHER INVESTIGATE THESE REPORTS AND DETERMINE ANY APPROPRIATE ACTIONS TO REDUCE THEIR OCCURRENCE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIOFIRE BCID PANEL IDENTIFIED PSUEDOMONAS AERUGINOSA AND ADDITIONAL ORGANISMS IN BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FOR PATIENT SAMPLES. WHEN THE SPECIMEN WAS SUB-CULTURED PSEUDOMONAS DID NOT GROW. RESULT WAS NOT REPORTED AND PATIENT TREATMENT WAS NOT AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS BOTTLES GAVE RESULT OF PSEUDOMONAS ON BIOFIRE"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOFIRE BCID PANEL IDENTIFIED PSUEDOMONAS AERUGINOSA AND ADDITIONAL ORGANISMS IN BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) FOR PATIENT SAMPLES. WHEN THE SPECIMEN WAS SUB-CULTURED PSEUDOMONAS DID NOT GROW. RESULT WAS NOT REPORTED AND PATIENT TREATMENT WAS NOT AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS BOTTLES GAVE RESULT OF PSEUDOMONAS ON BIOFIRE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475985 BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 0315673 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1