BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD AGAR WITH CHLORAMPHENICOL

    MDR report key: 12782148 · Received November 9, 2021

    Report

    Report Number
    9680577-2021-00077
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 13, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL CATALOG NUMBER 221851 WITH 510K NUMBER EXEMPT. 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 THE CUSTOMER FOUND ANOTHER CONTAMINATED PLATE IN PRODUCTION LOT 1223096. COMPLAINT HISTORY REVIEW: THE COMPLAINT TREND WAS REVIEWED FOR A PERIOD COVERING 12 MONTHS. SIMILAR COMPLAINTS WERE REGISTERED FOR LOT 1223096. SINCE THE TRENDING REACHED AN INTERNAL ACTION LIMIT, A INVESTIGATIONAL TEAM WAS FORMED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH RECORD FOR THE RESPECTIVE LOT WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESSES WERE REGISTERED. IN ADDITION, THE PRODUCT PASSED QC RELEASE TESTING WITHOUT ANY DEVIATIONS. SAMPLE ANALYSIS: RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW A PLATE CONTAMINATED BY A WHITE MICROORGANISM. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: ASEPTIC MANUFACTURING PROCESSES ARE UNABLE TO GUARANTEE STERILITY OF THE GIVEN PRODUCT. SINCE A 100 % INSPECTION IS NOT POSSIBLE FOR ASEPTIC PRODUCTS, STERILITY TESTING CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. THEREFORE, OCCASIONAL CONTAMINATION CANNOT BE PREVENTED. HOWEVER SINCE TREND WAS DETECTED, AN INTERDISCIPLINARY TEAM IS CURRENTLY DRIVING INVESTIGATIONS TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE ACTIONS TRIGGERED BY SAID TEAM. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SABOURAUD AGAR WITH CHLORAMPHENICOL WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS CONTACTED ME TO INFORM THAT THEY HAVE ANOTHER PLATE CONTAMINATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SABOURAUD AGAR WITH CHLORAMPHENICOL WERE CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS CONTACTED ME TO INFORM THAT THEY HAVE ANOTHER PLATE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681037 BD BBL¿ SABOURAUD AGAR WITH CHLORAMPHENICOL CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON GMBH 1223096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown