BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 11649706 · Received April 12, 2021

    Report

    Report Number
    9680577-2021-00014
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT CONTAMINATION WAS DETECTED ON SOME PLATES. THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. THERE WERE NO SIMILAR COMPLAINTS RECEIVED DURING THAT PERIOD ON THE BATCH NUMBERS. THEREFORE, A TREND COULD NOT BE IDENTIFIED. THE BATCH HISTORY REVIEWS DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION COULD BE DETECTED. PICTURES DOCUMENTING THE REPORTED CONTAMINATION WERE PROVIDED. BD HAS EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY, THEREFORE AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. THE VALID STANDARD FOR THESE PRODUCTS IS DIN EN 12322 "IN VITRO DIAGNOSTIC MEDICAL DEVICES - CULTURE MEDIA FOR MICROBIOLOGY". ACCORDING TO THIS STANDARD THE CONTAMINATION RATE FOR EACH PRODUCT LOT MUST NOT EXCEED 4.9%. BASED UPON OUR CONTINUOUS MONITORING, WE DERIVE A CONTAMINATION RATE THAT FALLS BELOW THIS SPECIFIED VALUE. ACCORDING TO OUR HIGH QUALITY STANDARD, WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 1.5. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE CONTAMINATED PLATES. BASED ON THE EVALUATION AND PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. SEE H10.

    Description of Event or Problem · 0

    "UNSTERILE PLATES WHICH ARE SEEN IN IRREGULAR INTERVALS - PLATES WITH GROWTH OF FUNGI ON IT. WHEN RECEIVING OUR PLATES, THE CUSTOMERS DETECTS FROM NOW AND THEN INDIVIDUAL PLATES WITH GROWTH ON IT (FUNGI)."

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1011743, MEDICAL DEVICE EXPIRATION DATE: 2021-04-20, DEVICE MANUFACTURE DATE: 2021-01-11. MEDICAL DEVICE LOT #: 0204563, MEDICAL DEVICE EXPIRATION DATE: 2020-10-25, DEVICE MANUFACTURE DATE: 2020-07-22.

    Description of Event or Problem · 1

    "UNSTERILE PLATES WHICH ARE SEEN IN IRREGULAR INTERVALS - PLATES WITH GROWTH OF FUNGI ON IT. WHEN RECEIVING OUR PLATES, THE CUSTOMERS DETECTS FROM NOW AND THEN INDIVIDUAL PLATES WITH GROWTH ON IT (FUNGI)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551552 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1