BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    MDR report key: 12929460 · Received December 3, 2021

    Report

    Report Number
    9680577-2021-00086
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 3, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT PRODUCT ARRIVED WITH A PLATE CONTAMINATED BY A MOLD. COMPLAINT TREND WAS ANALYZED FOR THE PAST 12 MONTHS. NO SIMILAR COMPLAINTS FOR LOT NUMBER 1200713 WERE REGISTERED. FOR CATALOG NUMBER 254071 ADDITIONAL CONTAMINATION COMPLAINTS WERE REPORTED IN THE PAST 12 MONTHS. TRENDING REACHED AN INTERNAL ACTION LIMIT AND AN INVESTIGATIONAL TEAM WAS FORMED. THE BHR WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PRODUCTION PROCESSES WERE REPORTED. ALL QC RELEASE TESTING WAS SATISFACTORY. RETURN SAMPLES WERE NOT PROVIDED FOR ANALYSIS. PICTURE SAMPLES PROVIDED BY THE CUSTOMER SHOW A PLATE COLUMBIA AGAR WITH 5 % SHEEP BLOOD OF LOT 1243747 AFFECTED BY A BIOLOGICAL CONTAMINATION. BASED ON THE PICTURES PROVIDED BY THE CUSTOMER AND THE INTERNAL INVESTIGATION, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATE FOUND IN UNOPENED BOX OF PLATES, SEEMS TO BE MOLD."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATE FOUND IN UNOPENED BOX OF PLATES, SEEMS TO BE MOLD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821167 BD¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1200713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown