BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 12297549 · Received August 9, 2021

    Report

    Report Number
    9680577-2021-00043
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 16, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST COLUMBIA AGAR WITH 5% SHEEP BLOOD, CATALOG NUMBER 254071, LOT NUMBER 1173789. IT WAS REPORTED THAT SOME PLATES WOULD BE CONTAMINATED. THE COMPLAINT TRENDS WERE REVIEWED. THERE WAS ONE SIMILAR CONFIRMED COMPLAINT REPORTED DURING THAT PERIOD ON THIS LOT NUMBER. THEREFORE, A TREND COULD NOT BE IDENTIFIED. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. A SAMPLE WAS NOT PROVIDED FOR FURTHER EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETENTION SAMPLE AND ONE STACK OF PLATES WERE INCUBATED. AS A RESULT OF THIS ANALYSIS NO CONTAMINATION WAS OBSERVED. BASED ON THE EVALUATION OF THE PROVIDED REPORT AND AS NO PICTURES WERE PROVIDED, THE COMPLAINT WAS NOT CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED MEDIA (BACTERIA GROWTH)".

    Additional Manufacturer Narrative · 1

    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¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 254071 WHICH IS A PREAMENDMENT DEVICE. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED MEDIA (BACTERIA GROWTH)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192780 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1173789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown