BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE TSA 5PRCT SB 90MM

    MDR report key: 22951748 · Received September 3, 2025

    Report

    Report Number
    9680577-2025-00417
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 31, 2024
    Report Date
    June 18, 2025
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSG
    UDI-DI
    30382902540879
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER RECEIVED TSA PLATE WITH MACCONKEY LABELING ON PLATE SLEEVE. THE CUSTOMER COMPLAINED ON INCORRECT LABELING ON PLATES SLEEVE OF TRYPTICASE SOY AGAR WITH 5% SB (254087) ALL PLATES SLEEVES CAME WITH MACCONKEY AGAR LABELLING INCLUDING WRONG CAT# AND LOT#. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD OF 12 MONTHS. NO SIMILAR COMPLAINTS WERE REVIEWED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. 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: THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION WAS DETECTED. RETURN SAMPLES WERE NOT PROVIDED BY THE CUSTOMER. PICTURE SAMPLES, PROVIDED BY THE CUSTOMER, SHOW STACKS OF TSA 5% SB PLATES SUB-LABELED BY A SUPPLIER WITH MACCONKEY II AGAR LABELLING INCLUDING WRONG CATALOG NUMBER 254078 AND LOT NUMBER 4170187. THE SUB-LABELING WAS NOT PERFORMED BY BD. THE BD LABEL PRINT ON THE CARTON BOX IS CORRECT. EVALUATION RESULTS: BASED ON THE INTERNAL INVESTIGATION AND THE PICTURE SAMPLES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR LABELING ISSUE. A TREND WAS NOT IDENTIFIED. THIS COMPLAINT IS TREATED AS AN ISOLATED INCIDENT. INVESTIGATION CONCLUSION: NO DEVIATIONS FROM OUR VALIDATED PROCESS PARAMETERS WERE IDENTIFIED. ALL QC RELEASE TESTING WAS SATISFACTORY. THE ROOT CAUSE OF THE LABELING ISSUE IS UNKNOWN. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD BBL¿ PLATE TSA 5PRCT SB 90MM THAT A CASE OF MEDIA CONTAINED PRODUCT INFORMATION FOR MACCONKEY II AGAR ON ALL SHELF PACK LABELS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386452 BD BBL¿ PLATE TSA 5PRCT SB 90MM CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON GMBH 4162813 30382902540879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown