BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CDC ANAEROBE 5% SB 100 EA JP

    MDR report key: 12448444 · Received September 9, 2021

    Report

    Report Number
    1119779-2021-01488
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 13, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CATALOG NUMBER 2221733 WITH 510K NUMBER K803025. INVESTIGATION SUMMARY: THE COMPLAINT WAS CONFIRMED AS THE REPORTED DEFECT ON A PICTURE. THE ISSUE WAS CONTAMINATION. WE OBSERVED SOME COLONIES ON THE AGAR BEDS. NO ISSUE IN BATCH HISTORY RECORD REVIEW AND QC ATTRIBUTE TEST THAT WE HELD. NO ISSUE IN RETENTION SAMPLE. WE COULD NOT DETERMINE ROOT CAUSE OF THIS ISSUE. NO TREND. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PLATE CDC ANAEROBE 5% SB 100 EA (B)(4) WAS CONTAMINATED WITH BACTERIA COLONIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WOULD LIKE TO FEEDBACK THAT THERE ARE A COUPLE OF CDC PLATES ((B)(4) PLATES) WHICH ARE CONTAMINATED WITH BACTERIA COLONIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344156 PLATE CDC ANAEROBE 5% SB 100 EA JP CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1159074

    Patients

    Seq Age Sex Outcome Treatment
    1