BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ GRAM CRYSTAL VIOLET

    MDR report key: 22915311 · Received August 28, 2025

    Report

    Report Number
    1119779-2025-04533
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 4, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JTS
    UDI-DI
    30382902125250
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY- THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE GRAM CRYSTAL VIOLET 250ML, CATALOG NUMBER 212525, BATCH 5071499, AND COMPLAINT #(B)(4) FOR SOLUTION APPEARANCE. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A BATCH HISTORY REVIEW OF GRAM CRYSTAL VIOLET. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE DEFECT IN QUESTION FOR THIS PRODUCT. NO RETURNS OR PHOTOS WERE RECEIVED. A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH OF CRYSTAL VIOLET. THE SOLUTION APPEARANCE OF RETENTION SAMPLE WAS SATISFACTORY AND COMPARABLE TO THE CONTROL; ALL WERE DEEP PURPLE SOLUTIONS WITH NO VISIBLE PRECIPITATE. SLIDES OF E. COLI ATCC 25922 AND S. AUREUS ATCC 25923 CONTROLS WERE EVALUATED AND HAD SATISFACTORY STAINING RESULTS FOR RETENTION AND CONTROL BATCHES. TEN FIELDS OF EACH SMEAR WERE EXAMINED IN DETAIL USING OIL IMMERSION LENS OF A LIGHT MICROSCOPE. NO EXCESSIVE PRECIPITATE, ARTIFACTS OR BACTERIAL CONTAMINATION WERE SEEN. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR SOLUTION APPEARANCE.

    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 WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BBL¿ GRAM CRYSTAL VIOLET THAT THERE WAS PRECIPITATE IN THE STAIN, WHICH APPEARED TO BE GRAM POSITIVE COCCI. AFTER MULTIPLE CUSTOMER FOLLOW UP ATTEMPTS BY BD THERE WAS NO INFORMATION PROVIDED REGARDING THE OCCURRENCE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698059 BD BBL¿ GRAM CRYSTAL VIOLET STAINS, MICROBIOLOGIC JTS BECTON DICKINSON & CO. (SPARKS) 5071499 30382902125250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown