BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 16678795 · Received April 4, 2023

    Report

    Report Number
    3008352382-2023-00031
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 10, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420222
    PMA / PMN Number
    K141810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG: 442022. BATCH NO. 3060945. 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 TWO CLSI STRAIN REFERENCES B. FRAGILIS (ATCC 25285) AND S. PNEUMONIAE (ATCC 6305). THE PI 8090999 (08) 2019-09 HAS ONE CLSI STRAIN REFERENCE B. FRAGILIS (ATCC 25285). 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 (B)(6) 23 TO CHANGE THE CLSI STRAIN REFERENCE. SINCE THE AFOREMENTIONED DATE BOTH COA¿S AND PI¿S CLSI STRAIN REFERENCES ARE THE SAME. QUALITY CONTROL CERTIFICATES LIST TEST ORGANISMS, INCLUDING ATCC® CULTURES SPECIFIED IN THE CLSI STANDARD M22, QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA. QUALITY CONTROL REQUIREMENTS MUST BE PERFORMED IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND/OR FEDERAL REGULATIONS OR ACCREDITATION REQUIREMENTS AND THE LABORATORY¿S STANDARD QUALITY CONTROL PROCEDURES. IT IS RECOMMENDED THAT THE USER REFER TO PERTINENT CLSI GUIDANCE AND CLIA REGULATIONS FOR APPROPRIATE QUALITY CONTROL PRACTICES. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) ORGANISMS MARKED AS CLSI STRAINS IN THE PI AND COAS DO NOT MATCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ORGANISMS MARKED AS CLSI STRAINS IN THE PI AND COAS DO NOT MATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) ORGANISMS MARKED AS CLSI STRAINS IN THE PI AND COAS DO NOT MATCH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ORGANISMS MARKED AS CLSI STRAINS IN THE PI AND COAS DO NOT MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730098 BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442022 3060945 00382904420222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown