BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL

    MDR report key: 16677352 · Received April 4, 2023

    Report

    Report Number
    1119779-2023-00388
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY DEAR VALUED CUSTOMER, THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST SABOURAUD AGAR SABOURAUD AGAR W/CHMP, CATALOG NUMBER 254091, LOT NUMBER 3017543 WITH RESPECT TO PACKAGING ISSUE. EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER OPENED THE BOXES (LOT 3017543), THE BAGS USED TO PRESERVE THE BOXES WERE OPEN AND THE AGARS WERE CONTAMINATED UPON RECEIPT. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. SIMILAR COMPLAINTS WERE REPORTED DURING THAT PERIOD OF TIME ON THIS PRODUCT. HOWEVER, A TREND COULD NOT BE DETECTED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. RETURNED SAMPLE ANALYSIS: RETAIN SAMPLES WERE REVIEWED, NEITHER CONTAMINATION NOR OPEN FOIL COULD BE IDENTIFIED. PHYSICAL SAMPLES WERE NOT RETURNED FOR EVALUATION. PICTURES WERE PROVIDED. BASED ON THE EVALUATION OF THE SHARED PICTURES CONTAMINATION AND PERFORATED FOIL COULD BE DETECTED. EVALUATION SUMMARY: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. 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. ACCORDING TO OUR HIGH-QUALITY STANDARD, WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 0,65. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. UNCAREFUL HANDLING OF THE BOXES DURING THE TRANSPORT/STORAGE CAN PERFORATE THE FOIL. HOWEVER, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: BASED ON THE ABOVE-MENTIONED EVALUATION THE COMPLAINT CAN BE CONFIRMED. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. BD REGRETS THE INCONVENIENCES YOU HAVE EXPERIENCED AND WILL CONTINUE TO MONITOR SIMILAR INCOMING COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D.3 COMMON DEVICE NAME: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL. E.6 INITIAL REPORTER E-MAIL: (B)(6). G5. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US, BUT IT 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 #EXEMPT. H.3. 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 WHILE USING THE BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGARS WERE CONTAMINATED UPON RECEIPT. THE CUSTOMER RECEIVED THE AGARS AND REALIZED THAT THEY WERE CONTAMINATED ON (B)(6) 2023 BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AGARS WERE CONTAMINATED UPON RECEIPT THE CUSTOMER RECEIVED THE AGARS AND REALIZED THAT THEY WERE CONTAMINATED ON 03/13/23 BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387071 BD BBL¿ SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL DEEP FILL SEE H.10 JSI BECTON, DICKINSON & CO. (SPARKS) 3017543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown