BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD

    MDR report key: 12095113 · Received June 30, 2021

    Report

    Report Number
    9680577-2021-00026
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 4, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    K760460
    Removal / Correction Number
    IDS-21-4201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQUIRED: RECALL H.9. REMEDIAL ACTION #: (B)(6). H.6. INVESTIGATION: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST PLATE SCHAEDLER AGAR / SCHAEDLER KV AGAR WITH 5% SHEEP BLOOD (BIPLATE) CATALOG NUMBER 257589, LOT NUMBER 1104468. EVENT DESCRIPTION: IT WAS REPORTED THAT ABOUT 25 PLATES OF 120 WOULD BE CONTAMINATED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. FOR THIS PRODUCT, SEVERAL COMPLAINTS WERE REPORTED FOR CONTAMINATION ISSUES. THEREFORE, A TREND WAS IDENTIFIED, AND FURTHER INVESTIGATION WAS PERFORMED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW WAS PERFORMED. AS PART OF THE INVESTIGATION, THE INGREDIENTS OF THIS MEDIUM WERE REVIEWED. DURING THIS REVIEW, NO DEVIATION WAS DETECTED. SAMPLE ANALYSIS: PICTURE SAMPLE WAS NOT PROVIDED FOR EVALUATION. RETAIN SAMPLES WERE REVIEWED FOR THIS LOT. DURING THIS REVIEW, CONTAMINATION COULD BE DETECTED. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. A MATERIAL REVIEW BOARD (MRB) WAS CONDUCTED WHICH LED TO A SITUATION ANALYSIS (SA) WHICH EVENTUALLY RESULTED IN A RECALL. THE PERFORMED INVESTIGATION SHOWED THAT THE ORIGIN OF THE CONTAMINATION WAS ASSOCIATED WITH AN ANAEROBIC MICROORGANISM GROWING AT LOWER TEMPERATURES (<22°C). THIS MICROORGANISM WAS DETECTED FOR THE FIRST TIME AT THE PRODUCTION SITE. THEREFORE, AND AS NO CONTAMINATION COMPLAINTS WERE RECEIVED IN CONJUNCTION WITH THE RESPECTIVE PRODUCT WITHIN THE PAST YEAR THIS EVENT WAS CONCLUDED TO BE A SINGLE INCIDENT. HOWEVER, REGARDING THE REPORTED CONTAMINATION, PLEASE NOTE THAT 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. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE REPORT THE COMPLAINT IS CONFIRMED. AN MRB WAS INITIATED AND A SA WAS PERFORMED FOR CONTAMINATION ISSUE, WHICH LED TO A RECALL. WE WOULD SUGGEST TO SET ASIDE, AND NOT USE, ANY PREPARED PLATED MEDIA 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.

    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¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221555 WITH 510K NUMBER K760460. 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 THE BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD PLATES WERE CONTAMINATED. THIS OCCURRED WITH 25 PLATES, HOWEVER, THE PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH 1104468 OF THE BI-PLATES IS AFFECTED. THERE IS A CONTAMINATION ON THE SCHAEDLER SIDE IN ALMOST A THIRD OF THE PLATES. AROUND 25 PLATES OF 120 WERE CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD PLATES WERE CONTAMINATED. THIS OCCURRED WITH 25 PLATES, HOWEVER, THE PATIENT IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH 1104468 OF THE BI-PLATES IS AFFECTED. THERE IS A CONTAMINATION ON THE SCHAEDLER SIDE IN ALMOST A THIRD OF THE PLATES. AROUND 25 PLATES OF 120 WERE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988058 BD BBL¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1104468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown