BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16678797 · Received April 4, 2023

    Report

    Report Number
    2647876-2023-00012
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420208
    PMA / PMN Number
    K151866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG: 442020. BATCH NO. 3060952. 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 P. AERUGINOSA (ATCC 27853) AND S. PNEUMONIAE (ATCC 6305). THE PI 500008334 (05) 2019-09 HAS ONE CLSI STRAIN REFERENCE S. PNEUMONIAE (ATCC 6305). 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. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE ORGANISMS MARKED AS CLSI STAINS IN PI AND COAS DON'T MATCH

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE ORGANISMS MARKED AS CLSI STAINS IN PI AND COAS DON'T MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730100 BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442020 3060952 00382904420208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown