BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC; LYTIC/10 ANAEROBIC/F CULTURE VIALS

    MDR report key: 11363251 · Received February 22, 2021

    Report

    Report Number
    3008352382-2021-00050
    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
    00382904422653
    PMA / PMN Number
    K954925
    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: 442021; BATCH NO.: 9121604 & 9177949 EXPIRED. CUSTOMER REPORTED A POSITIVE PSEUDOMONAS AERUGINOSA ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. NO INVESTIGATION WILL BE CONDUCTED. BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR PRODUCT RELEASE. 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. BD 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 DURING BIOFIRE TESTING WITH BD BACTEC¿; LYTIC/10 ANAEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED FOR PSEUDOMONAS. 2 RESULTS WERE REPORTED OUT AND 2 PATIENTS WERE TREATED BASED OF RESULTS. 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 #: 9121604. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2019-05-01. MEDICAL DEVICE LOT #: 9177949. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2019-06-26. 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 THAT DURING BIOFIRE TESTING WITH BD BACTEC¿; LYTIC/10 ANAEROBIC/F CULTURE VIALS FALSE POSITIVE RESULTS WERE OBTAINED FOR PSEUDOMONAS. 2 RESULTS WERE REPORTED OUT AND 2 PATIENTS WERE TREATED BASED OF RESULTS. 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
    254607 BD BACTEC; LYTIC/10 ANAEROBIC/F CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442265 SEE H.10 00382904422653

    Patients

    Seq Age Sex Outcome Treatment
    1