BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, PLATE, 90 MM X 120MM

    MDR report key: 15126639 · Received July 28, 2022

    Report

    Report Number
    9680577-2022-00088
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    July 4, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSE
    UDI-DI
    03829025409610
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY EVENT DESCRIPTION: IT WAS REPORTED THAT SEVERAL PLATES WOULD NOT BE SELECTIVE. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY HAS BEEN REVIEWED AND FOR THIS PRODUCT, SEVERAL COMPLAINTS WERE REPORTED FOR A PERFORMANCE ISSUE. THEREFORE, A TREND WAS IDENTIFIED, AND FURTHER INVESTIGATION WAS PERFORMED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY HAS BEEN REVIEWED. IT WAS IDENTIFIED THAT THE CHLORAMPHENICOL CONTAINING IN THIS PRODUCT WAS PROBABLY AFFECTED AND FURTHER FINISHED PRODUCTS WERE IDENTIFIED. SAMPLE ANALYSIS: A PERFORMANCE TEST HAS BEEN CONDUCTED ON THE RETAIN SAMPLES OF THE COMPLAINED BATCH 2150314. THE RESULTS SHOWED NOT DEVIATION; HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED. RETURN SAMPLES AND PICTURES DOCUMENTING THE ISSUE WERE NOT PROVIDED. EVALUATION RESULTS AND INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMATIC FAILURE IN OUR MANUFACTURING PROCESS. ALL THE RELEASE TESTING WAS SATISFACTORY AND ALSO THE RETEST PERFORMED ON THE RETAIN SAMPLES OF THE COMPLAINED BATCH 2150314 DID NOT REVEAL ANY DEVIATION TO THE REQUIREMENT. HOWEVER WHILE TESTING OTHER BATCHES CONTAINING CHLORAMPHENICOL, THE PERFORMANCE ISSUE COULD BE CONFIRMED FOR EXCESSIVE GROWTH. BD HAS IDENTIFIED AN OUTSIDE SUPPLIER ISSUE WITH THIS PLATE¿S IMPREGNATED ANTIBIOTIC, CHLORAMPHENICOL, WHICH RESULTS IN A REDUCTION IN THE ANTIBACTERIAL ACTIVITY OF THE CHLORAMPHENICOL OVER THE SHELF LIFE OF THE AGAR. AS A RESULT A PRODUCT RECALL HAS BEEN INITIATED FOR THE AFFECTED LOTS IN THE AFFECTED REGIONS. BASED ON THE ABOVE MENTIONED EVALUATION, THIS COMPLAINT WAS CONFIRMED. BD REGRETS THE INCONVENIENCES YOU HAVE BEEN EXPERIENCING DUE TO THIS ISSUE AND BD WILL CONTINUE MONITORING INCOMING COMPLAINT WITH SIMILAR FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF BD¿ SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, PLATE, 90 MM X 120 MM WERE FOUND TO BE CONTAMINATED WITH BIOLOGICAL MATTER. THIS IS A REPORT OF 9 OCCURRENCES. PLATES WERE NOT USED FOR TESTING, THEREFORE THERE WERE NO FALSE RESULTS TO REPORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE PLATES WE SEE THE CONTINUED GROWTH OF VARIOUS MICRO-ORGANISMS IN THE PAST WEEK WE HAVE SEEN; S.HAEMOLYTICUS, PROTEUS SPP AND PSEUDOMONAS SSP. THIS SHOULD ACTUALLY NOT BE ALLOWED. PLEASE SEND US A NEW SHIPMENT FOR THIS FREE OF CHARGE WITH ANOTHER BATCH NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF BD¿ SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, PLATE, 90 MM X 120 MM WERE FOUND TO BE CONTAMINATED WITH BIOLOGICAL MATTER. THIS IS A REPORT OF 9 OCCURRENCES. PLATES WERE NOT USED FOR TESTING, THEREFORE THERE WERE NO FALSE RESULTS TO REPORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE PLATES WE SEE THE CONTINUED GROWTH OF VARIOUS MICRO-ORGANISMS IN THE PAST WEEK WE HAVE SEEN; S.HAEMOLYTICUS, PROTEUS SPP AND PSEUDOMONAS SSP THIS SHOULD ACTUALLY NOT BE ALLOWED PLEASE SEND US A NEW SHIPMENT FOR THIS FREE OF CHARGE WITH ANOTHER BATCH NUMBER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427075 BD¿ SABOURAUD AGAR WITH GENTAMICIN AND CHLORAMPHENICOL, PLATE, 90 MM X 120MM UNKNOWN JSE BECTON DICKINSON GMBH 2150314 03829025409610

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown