BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CHOCO GC AGAR W/ISOVITALEX 90MM

    MDR report key: 11916819 · Received June 1, 2021

    Report

    Report Number
    9680577-2021-00017
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSO
    PMA / PMN Number
    K945569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1076973. MEDICAL DEVICE EXPIRATION DATE: 2021-06-14. DEVICE MANUFACTURE DATE: 2021-03-17. MEDICAL DEVICE LOT #: 1069887. MEDICAL DEVICE EXPIRATION DATE: 2021-06-08. DEVICE MANUFACTURE DATE: 2021-03-10. 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¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT CATALOG NUMBER 221240 WHICH HAS 510K NUMBER K945569.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PLATES WOULD BE COMPLETELY WITHOUT A LABEL. IN THIS CASE, IT WAS NOT POSSIBLE TO VERIFY WHETHER IT IS BATCH 1076973 OR 1069887. THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. THERE WAS ONE SIMILAR COMPLAINT RECEIVED DURING THAT PERIOD OF TIME ON THIS PRODUCT. THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. PICTURE SAMPLE WAS PROVIDED SHOWING PARTIALLY PRINTED PLATES AND ONE PLATE WITHOUT ANY BOTTOM PRINT. THE RETAIN SAMPLES WERE REVIEWED AND IT WAS DETECTED THAT SEVERAL BATCH NUMBERS WERE AFFECTED. FURTHER INVESTIGATION WAS PERFORMED AND DOCUMENTED WITHIN CAPA 2793743. BASED ON THE EVALUATION OF THE REPORT THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 171 PLATE CHOCO GC AGAR W/ISOVITALEX 90MM A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLATES ARE COMPLETELY WITHOUT A LABEL. SINCE THE BOXES ARE ALREADY GONE, IT IS NOT POSSIBLE TO VERIFY WHETHER IT IS BATCH 1076973 OR 1069887."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 171 PLATE CHOCO GC AGAR W/ISOVITALEX 90MM A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLATES ARE COMPLETELY WITHOUT A LABEL. SINCE THE BOXES ARE ALREADY GONE, IT IS NOT POSSIBLE TO VERIFY WHETHER IT IS BATCH 1076973 OR 1069887.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812269 PLATE CHOCO GC AGAR W/ISOVITALEX 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON JSO BECTON DICKINSON GMBH SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1