BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE GC LECT AGAR 90MM 20

    MDR report key: 11586352 · Received March 29, 2021

    Report

    Report Number
    9680577-2021-00012
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 4, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JTY
    PMA / PMN Number
    K864803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.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-LECT¿ AGAR CATALOG NUMBER 297715 WHICH HAS 510K NUMBER K864803

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT (B)(4) AGAINST GC-LECT¿ AGAR, CATALOG NUMBER 254554, LOT NUMBER 1011700. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING THE QC TESTING AT CUSTOMERS SIDE THE NEISSERIA GONORRHOEAE WOULD NOT GROW. HOWEVER, THE CUSTOMER REPORTED THAT THEIR STRAINS DID NOT WORK WELL AND THE BD PRODUCT WOULD NOT HAVE BEEN AFFECTED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY REVIEW WAS PERFORMED FOR A PERIOD OF 12 MONTHS AND NO SIMILAR COMPLAINTS WERE FOUND TO BE REPORTED FOR THIS PRODUCT. THEREFORE, A TREND COULD NOT BE 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. SAMPLE ANALYSIS: THE INITIAL QC PERFORMANCE TEST WAS REVIEWED AND NO DEFICIENCIES WERE DETECTED. EVALUATION SUMMARY: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. NO DEVIATIONS COULD BE DETERMINED NEITHER DURING IN-PROCESS CONTROL NOR DURING QC RELEASE. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE PROVIDED REPORT AND AS THE CUSTOMER REPORTED THAT THE BD PRODUCT WAS NOT AFFECTED, THE COMPLAINT WAS CONFIRMED. A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE IMPLEMENTED AS A TREND COULD NOT BE IDENTIFIED. WE WOULD SUGGEST THAT ANY PREPARED PLATED MEDIA BE SET ASIDE, AND NOT USE, THAT DOES NOT MEET THE APPEARANCE SPECIFICATION AS IT IS DESCRIBED ON THE BD CERTIFICATE OF ANALYSIS. THIS IS CONSISTENT WITH INDUSTRY RECOMMENDATIONS FOR INSPECTION OF CULTURE MEDIA PRIOR TO USE (E.G. ¿GOOD PRACTICES FOR PHARMACEUTICAL MICROBIOLOGY LABORATORIES¿, WHO TECHNICAL REPORT SERIES, NO. 961, 2011, ANNEX 2; CHAPTER 1117 ¿MICROBIOLOGY BEST LABORATORY PRACTICES¿ THE UNITED STATES PHARMACOPEIA; AND THE DIFCO & BBL MANUAL). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE GC LECT AGAR 90MM 20 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE GC LECT AGAR 90MM 20 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483898 PLATE GC LECT AGAR 90MM 20 CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA JTY BECTON DICKINSON GMBH 1011700

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown