BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE COLUMBIA AG 5PRCT SB 90MM

    MDR report key: 19721503 · Received July 11, 2024

    Report

    Report Number
    9680577-2024-00019
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    KZI
    UDI-DI
    30382902540718
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). EVENT DESCRIPTION: IT WAS REPORTED THAT THERE IS NO PRINT ON THE BACK OF THE PLATE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR COMPLAINT WAS IDENTIFIED FOR THIS CATALOG NUMBER. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. THE IN-PROCESS CONTROL FOR THE PRINT TEST WAS FOUND WITHOUT DEVIATION. SAMPLE ANALYSIS: RETAIN SAMPLES WERE REVIEWED AND NO PLATE WITHOUT A PLATE PRINT COULD BE IDENTIFIED. PHYSICAL SAMPLES WERE NOT RETURNED FOR EVALUATION. HOWEVER, PICTURE SAMPLES WERE PROVIDED SHOWING THAT THE PLATE PRINT ON THE BOTTOM OF THE PLATE, WHICH INCLUDES THE BATCH NUMBER AND EXPIRY DATE, WAS MISSING. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. IN THIS CASE 108.000 PLATES WERE PRODUCED, AND THE FAILURE OF THE MISSING PRINT WAS DETECTED ON 200 PLATES BY THE CUSTOMER. NO OTHER COMPLAINT WAS REGISTERED FOR THIS LOT NUMBER. BASED ON THE EVALUATION OF THE PROVIDED PICTURES, AND REPORT, THE COMPLAINT WAS CONFIRMED FOR A MISSING PLATE PRINT INCLUDING THE BATCH NUMBER AND THE EXPIRY DATE. AS NO FURTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEFECT, ALL IN-PROCESS CONTROLS WERE WITHOUT DEVIATION, NO DEVIATIONS WERE OBSERVED IN THE BATCH HISTORY RECORD, AND THE AQL HAS NOT BEEN VIOLATED WITH A PERCENTAGE OF 0.2 %, THERE ARE NO CORRECTIVE ACTIONS INDICATED AT THIS TIME. HOWEVER, BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR THIS TYPE OF DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PLATE COLUMBIA AG 5PRCT SB 90MM THAT THE BATCH NUMBER AND EXPIRATION DATE WERE MISSING FROM THE PLATE. THIS OCCURRED ON TWO-HUNDRED AND FORTY PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379783 PLATE COLUMBIA AG 5PRCT SB 90MM CULTURE MEDIA, ENRICHED KZI BECTON DICKINSON GMBH 4113723 30382902540718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown