BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 12911546 · Received December 1, 2021

    Report

    Report Number
    9680577-2021-00088
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    October 25, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT CONTAMINATION WAS DETECTED WHEN OPENING THE PLASTIC BAG. COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE RECORDED FOR THE RESPECTIVE BATCH. HOWEVER, SINCE THIS PRODUCT IS FILLED ASEPTICALLY WITH AN AQL FOR STERILITY OF 1.5 RARE CONTAMINATION EVENTS ARE TO BE EXPECTED. THEREFORE A TREND COULD NOT BE IDENTIFIED. THE BHR WAS REVIEWED. NO DEVIATION FROM THE VALIDATED PROCESSES AND PARAMETERS WERE REGISTERED. PLATES WERE EXPIRED ON THE DATE OF COMPLAINT ENTRY. THEREFORE RETAIN SAMPLES WERE UNAVAILABLE FOR INVESTIGATION. PICTURE SAMPLE WAS NOT PROVIDED. AT THIS STAGE OF OUR INVESTIGATION, WE HAVE 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. PLEASE NOTE THAT 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 (B)(4) . 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 OF THE REPORT, AND AS NO PICTURES WERE PROVIDED AND THE PRODUCT ALREADY EXPIRED, THE COMPLAINT WAS NOT CONFIRMED.

    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¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221263 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE. 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 PRIOR TO USE, PLATE COLUMBIA AG 5PRCT SB 90MM WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. NOTE: CONTAMINATION WAS FOUND AFTER PRODUCT EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES OBSERVED WHEN OPENING PLASTIC BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, PLATE COLUMBIA AG 5PRCT SB 90MM WERE CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. NOTE: CONTAMINATION WAS FOUND AFTER PRODUCT EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATED PLATES OBSERVED WHEN OPENING PLASTIC BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810612 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1194907

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown