BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR

    MDR report key: 13792881 · Received March 17, 2022

    Report

    Report Number
    1119779-2022-00438
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 18, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    PMA / PMN Number
    K803025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 252467, LOT# 1342900. THE COMPLAINT WAS NOT CONFIRMED AS THE REPORTED DEFECT ON A PICTURE. WE CONFIRMED NO ISSUE IN PHOTO. WE ONLY CONFIRMED WATER SPOT MARK ON THE AGAR SURFACE. THIS PHENOMENON IS IN SPEC QC ATTRIBUTE TEST. WE CANNOT CONTROL THE MOISTURE DURING TRANSPORTATION. WE HAVEN'T HAD SAME REPORT FROM OTHER CUSTOMER. NO ISSUE IN DHR. NO ISSUE IN RETENTION SAMPLE. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION AND WATER MARKS. THIS EVENT OCCURRED 5 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE SOME BACTERIA ON THE PLATE WITH WATER MARKS 1-3, BUT NONE OF THEM GROW. JUST A BUNCH OF WATER MARKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766047 BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON, DICKINSON & CO. (SPARKS) 1342900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown