BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SABOURAUD AGAR PLATE WITH GENTAMYCIN AND CHLORAMPHENICOL

    MDR report key: 12977816 · Received December 10, 2021

    Report

    Report Number
    9680577-2021-00091
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 15, 2021
    Report Date
    March 2, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT LOT 1264042 CONTAINED CONTAMINATED PLATES. THE COMPLAINT TREND WAS REVIEWED FOR A PERIOD COVERING 12 MONTHS. SIMILAR COMPLAINTS WERE IDENTIFIED FOR THE SAME PRODUCT GROUP. AN INTERNAL ACTION LIMITS WERE NOT REACHED, A TREND WAS NOT IDENTIFIED. 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. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW A PLATE OF LOT 1264042 AFFECTED BY A MICROBIAL CONTAMINATION WITH A MOLD. BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR CONTAMINATION. NEITHER A TREND NOR A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED. THIS COMPLAINT IS TREATED AS AN ISOLATED INCIDENCE. CATALOG NUMBER 254041 IS FILLED UNDER ASEPTIC CONDITIONS. THEREFORE STERILITY OF THE FINISHED PRODUCT CANNOT BE GUARANTEED. UNFORTUNATELY A 100 % INSPECTION LEVEL FOR STERILITY IS NOT POSSIBLE AND STERILITY TESTING IS CARRIED OUT ON THE BASIS OF A REPRESENTATIVE SAMPLE. IN CONSEQUENCE, OCCASIONAL CONTAMINATIONS CANNOT BE PREVENTED. TO IMPROVE CUSTOMER EXPERIENCE, A CROSS-FUNCTION TEAM IS DRIVING ACTIONS TO FURTHER REDUCE THE OCCURRENCE OF THESE SUBLIMINAL CONTAMINATIONS. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 THE BD¿ SABOURAUD AGAR PLATE WITH GENTAMYCIN AND CHLORAMPHENICOL WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "CONTAMINATED PLATES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SABOURAUD AGAR PLATE WITH GENTAMYCIN AND CHLORAMPHENICOL WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "CONTAMINATED PLATES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876465 BD¿ SABOURAUD AGAR PLATE WITH GENTAMYCIN AND CHLORAMPHENICOL CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1264042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown