BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS

    MDR report key: 16678792 · Received April 4, 2023

    Report

    Report Number
    3008352382-2023-00030
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG: 442288; BATCH NO. 3033465. CUSTOMER REPORTS THAT THE CLSI STRAINS MENTIONED IN CERTIFICATE OF ANALYSIS (COA) DOES NOT MATCH THOSE IN THE PRODUCT INSERT (PI). COA AND PI WERE ATTACHED AS EVIDENCE. BIOLOGICAL PERFORMANCE SECTION IN THE COA AND THE PI WERE EVALUATED. COA HAS CLSI STRAIN REFERENCES C. GLABRATA (ATCC (B)(4)) C. NEOFORMANS (ATCC (B)(4)) M. FORTUITUM (ATCC (B)(4)) M. INTRACELLULARE (ATCC (B)(4)) M. KANSASII (ATCC (B)(4)) M. TUBERCULOSIS, H37RA (ATCC (B)(4)). THE PI (B)(4) (07) 2019-08 HAS NO CLSI STRAIN REFERENCE. BATCH HISTORY RECORDS REVIEW WAS PERFORMED. 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. COMPLAINT IS CONFIRMED. AN ENGINEERING CHANGE CONTROL WAS COMPLETED ON 10APR23 TO CHANGE THE CLSI STRAIN REFERENCE TO THE COA. A CHANGE CONTROL WAS INITIATED TO ADD THE CLSI STRAIN REFERENCE TO THE PI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THE ORGANISMS LISTED AS CLSI STRAINS ON PI AND COAS DON'T MATCH THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE ORGANISMS LISTED AS CLSI STRAINS ON PI AND COAS DON'T MATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THE ORGANISMS LISTED AS CLSI STRAINS ON PI AND COAS DON'T MATCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE ORGANISMS LISTED AS CLSI STRAINS ON PI AND COAS DON'T MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795437 BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 3033465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown