BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 14190807 · Received April 22, 2022

    Report

    Report Number
    9680577-2022-00061
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 9, 2022
    Report Date
    July 5, 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

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

    Additional Manufacturer Narrative · 0

    H.10 MANUFACTURE NARRATIVE: COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED AND A TREND WAS IDENTIFIED FOR THIS PRODUCT. BATCH HISTORY RECORD (BHR) REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED MANUFACTURING PROCESSES WERE IDENTIFIED. SAMPLE ANALYSIS: RETAIN SAMPLES WERE REVIEWED AND INCUBATED. NO CONTAMINATION OBSERVED AFTER THE INCUBATION. RETURN SAMPLES WERE NOT PROVIDED AND THE CONTAMINATION CANNOT BE IDENTIFIED ON THE SHARED PICTURE. EVALUATION RESULTS: THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED. IN THIS CASE, A TREND WAS IDENTIFIED. CURRENTLY SEVERAL CROSS-FUNCTIONAL TEAMS ARE CONDUCTING EXTENSIVE INVESTIGATION TO REDUCE THE OCCURRENCE FOR SUCH SUBLIMINAL CONTAMINATIONS. PLEASE BE AWARE THAT SUCH INVESTIGATION WILL TAKE ITS TIME. A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. INVESTIGATION CONCLUSION: ALTHOUGH CONTAMINATION COULD NOT BE OBSERVED ON THE SHARED PICTURE AND AFTER THE INCUBATION, THE COMPLAINT CAN BE CONFIRMED BASED ON THE TREND THAT WAS IDENTIFIED. A THOROUGH INVESTIGATION IS CURRENTLY BEING PERFORMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 1 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: CUSTOMER FOUND A PLATE WITH CONTAMINATION, IDENTIFIED IN MALDITOF AS BACILLUS IDRIENSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM THE CUSTOMER OBSERVED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 1 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: "CUSTOMER FOUND A PLATE WITH CONTAMINATION, IDENTIFIED IN MALDITOF AS BACILLUS IDRIENSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742763 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 1361180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown