BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20

    MDR report key: 13206630 · Received January 10, 2022

    Report

    Report Number
    9680577-2021-00106
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 15, 2021
    Report Date
    May 10, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL AND GENTAMICIN DEEP FILL CATALOG NUMBER 296359 WITH AN EXEMPT 510K NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THERE WOULD BE PERFORMANCE ISSUES WITH ESCHERICHIA COLI AND STAPHYLOCOCCUS AUREUS. COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE NOTICED FOR THIS PRODUCT. A TREND WAS NOT IDENTIFIED. THE BHR WAS REVIEWED. NO RELEVANT PROCESS DEVIATION WAS REGISTERED. RETAIN SAMPLES WERE ANALYZED. GROWTH PROMOTION WAS TESTED ACCORDING TO F-55084. NO DEVIATIONS WERE DETECTED. AT THIS STAGE OF OUR INVESTIGATION, SYSTEMIC FAILURES OF THE VALIDATED MANUFACTURING PROCESSES CAN BE EXCLUDED. QC RELEASE TESTING OF THE AFFECTED LOT WAS SATISFACTORY. ANALYSIS OF THE COMPLAINT HISTORY SHOWED NO TRENDING OR VIOLATION OF ACTION LIMITS. BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT WAS NOT BE CONFIRMED. NO FURTHER COMPLAINTS REGARDING THIS PRODUCT WERE NOTICED AND ALL ANALYSIS DONE BY THE QC DEPARTMENT YIELDED SATISFACTORY RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 EXPERIENCED BACTERIA PRESENT IN THE SAMPLES BEING GROWN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDIUM IS NOT SELECTIVE AT ALL:ALL BACTERIA PRESENT IN THE SAMPLE GROW ON IT. WERE PLATES RECEIVED IN GOOD CONDITION? YES. WHAT ORGANISMS ARE NOT BEING INHIBITED? ESCHERICHIA COLI ET STAPHYLOCOCCUS AUREUS. DID THEY TEST QC? NO. IF SO - WHAT STRAINS WERE USED AND WHAT WERE THE RESULTS? WERE ANY PATIENTS INVOLVED? NO, AS THEY COULD DETECT YEASTS AND FUNGI ON TSA + SB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 EXPERIENCED BACTERIA PRESENT IN THE SAMPLES BEING GROWN. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MEDIUM IS NOT SELECTIVE AT ALL:ALL BACTERIA PRESENT IN THE SAMPLE GROW ON IT. 1) WERE PLATES RECEIVED IN GOOD CONDITION? YES 2) WHAT ORGANISMS ARE NOT BEING INHIBITED? ESCHERICHIA COLI ET STAPHYLOCOCCUS AUREUS 3) DID THEY TEST QC? NO IF SO - WHAT STRAINS WERE USED AND WHAT WERE THE RESULTS? 4) WERE ANY PATIENTS INVOLVED? NO, AS THEY COULD DETECT YEASTS AND FUNGI ON TSA + SB

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981240 BD BBL¿ PLATE SABOURAUD AG W/GENT W/CHMP 90MM 20 CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1313140

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown