BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPLATE SCHAEDLER/SCHAED KV 5% SB 20

    MDR report key: 12104040 · Received July 1, 2021

    Report

    Report Number
    9680577-2021-00028
    Event Type
    Malfunction
    Date Received
    July 1, 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

    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¿ SCHAEDLER K-V AGAR WITH 5% SHEEP BLOOD CATALOG NUMBER 221555 WHICH HAS 510K NUMBER K760460.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQUIRED: RECALL. H.9. REMEDIAL ACTION #: (B)(4). H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT AGAINST PLATE SCHAEDLER AGAR / SCHAEDLER KV AGAR WITH 5% SHEEP BLOOD (BIPLATE) CATALOG NUMBER 254476, LOT NUMBER 1104468. EVENT DESCRIPTION: IT WAS REPORTED THAT SOME PLATES WOULD SHOW CONTAMINATON ON THE MEDIUM. 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 PROVIDED FOR EVALUATION. BASED ON THE PICTURE, THE SCHAEDLER AGAR SIDE WAS FOUND TO BE CONTAMINATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIPLATE SCHAEDLER/SCHAED KV 5% SB 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATES"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIPLATE SCHAEDLER/SCHAED KV 5% SB 20 CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED PLATES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995436 BIPLATE SCHAEDLER/SCHAED KV 5% SB 20 CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1104468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown