BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC; PLUS AEROBIC/F CULTURE VIALS

    MDR report key: 11363250 · Received February 22, 2021

    Report

    Report Number
    3008352382-2021-00049
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 13, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CATALOG: 442023, BATCH NO.: 0283856 & 0301016. CUSTOMER REPORTED A POSITIVE PSEUDOMONAS AERUGINOSA ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE PERFORMING BIOFIRE TESTING WITH BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED FOR PSEUDOMONAS. TWO RESULTS WERE REPORTED AND TWO PATIENTS WERE TREATED.MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0093305, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2020-04-02, MEDICAL DEVICE LOT #: 0283856, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2020-10-09, MEDICAL DEVICE LOT #: 0301016, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2020-10-27. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING BIOFIRE TESTING WITH BD BACTEC¿; PLUS AEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED FOR PSEUDOMONAS. TWO RESULTS WERE REPORTED AND TWO PATIENTS WERE TREATED.MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER HAS NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254606 BD BACTEC; PLUS AEROBIC/F CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H.10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1