BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM

    MDR report key: 12215035 · Received July 22, 2021

    Report

    Report Number
    9680577-2021-00033
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 24, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE FINDINGS ON THE RECENT COMPLAINT 3171962 AGAINST SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, CATALOG NUMBER 254096, LOT NUMBER 1112582. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PLATES WERE FOUND TO BE CONTAMINATED IN THEIR UNOPENED SLEEVES. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY OF THE AFFECTED BATCH AND CATALOG NUMBER WAS REVIEWED FOR THE PAST 12 MONTHS. THERE WERE NO SIMILAR COMPLAINTS REGISTERED. THEREFORE A TREND COULD NOT BE IDENTIFIED. DHR REVIEW: THE BHR WAS REVIEWED. NO DEVIATIONS FROM VALIDATED PROCESSES WERE REGISTERED. FURTHERMORE THE AFFECTED BATCH MET ALL REQUIRED RELEASE SPECIFICATIONS AND NO DEVIATION WAS REGISTERED DURING QC RELEASE TESTING. STERILIZATION RECORD REVIEW: THE MEDIUM ITSELF IS HEAT STERILIZED. HOWEVER, THIS PRODUCT IS FILLED UNDER ASEPTIC CONDITIONS. SINCE A 100 % CONTROL FOR STERILITY IS NOT POSSIBLE A REPRESENTATIVE SAMPLING IS DONE BY THE QC DEPARTMENT. LOT NO. 1112582 COMPLIED TO OUR INTERNAL ACCEPTANCE QUALITY LIMIT (AQL) FOR STERILITY. SAMPLE ANALYSIS: A PICTURE SAMPLE WAS NOT PROVIDED FOR FURTHER EVALUATION. A PICTURE SAMPLE WAS NOT PROVIDED FOR FURTHER EVALUATION. 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. NEVERTHELESS, TO IMPROVE CUSTOMER EXPERIENCE, AN INTERDISCIPLINARY TEAM WAS FOUNDED TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. EFFECTIVENESS CHECKS INDICATE A SIGNIFICANT IMPROVEMENT TO THE SITUATION CAUSED BY THE TRIGGERED ACTIONS. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND AS NO PICTURES WERE PROVIDED, THE COMPLAINT WAS NOT CONFIRMED. NEITHER A TREND NOR A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM MOLD 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: " IN RELATION TO ORDER NO. (B)(4) OF 19/05/21 WE FOUND ON THE SABOURAUD PRODUCT LOT 1112582 EXP. 23/07/2021 THE PRESENCE OF MOLD CONTAMINATION INSIDE THE PLATES STILL SEALED AND PROPERLY STORED. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT 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" SABOURAUD DEXTROSE AGAR WITH CHLORAMPHENICOL AND GENTAMICIN DEEP FILL CATALOG NUMBER 296359 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM MOLD 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: '' IN RELATION TO ORDER NO. 32214630 OF 19/05/2021 WE FOUND ON THE SABOURAUD PRODUCT LOT 1112582 EXP. 23/07/2021 THE PRESENCE OF MOLD CONTAMINATION INSIDE THE PLATES STILL SEALED AND PROPERLY STORED.''

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109518 PLATE SABOURAUD AGAR W/GENT W/CHMP 90MM CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1112582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown